Contraception & Reproduction Module 2023 PDF

Contraception Sarah E. Kubes PharmD, BCPPS Clinical Assistant Professor College of Pharmacy, The University of Texas at Austin Adjoint Assistant Professor School of Medicine, University of Texas Health Science Center at San Antonio Pediatric Clinical Specialist Pharmacist University Health System Up...

Contraception Sarah E. Kubes PharmD, BCPPS Clinical Assistant Professor College of Pharmacy, The University of Texas at Austin Adjoint Assistant Professor School of Medicine, University of Texas Health Science Center at San Antonio Pediatric Clinical Specialist Pharmacist University Health System Updated 3.30.2023 by Melanie Sokol PharmD Candidate 2023 Objectives Understand the role of sex hormones in the female reproductive cycle 1 Evaluate nonhormonal methods of contraception 2 Compare different hormonal contraceptives 5 Design a contraceptive plan based on patient specific factors 3 Explain contraindications to different types of contraceptives 4 Explain indications for emergency contraceptive use Terminology and Definitions • • • • • • Assigned sex at birth: The sex (male or female) assigned to a child at birth, most often based on the child’s external anatomy Cisgender: Someone whose gender Identity corresponds with their sex assigned at birth Female: A biological denotation; denotes the sex that can bear offspring or produce eggs Female-to-male (or transgender man): Someone with a male gender identity and a female assigned sex at birth Gender: Used to describe the characteristics of women and men that are socially constructed Gender identity: A personal conception of oneself as man or woman (or rarely, both or neither) • Male: A biological denotation; denotes the sex that produces small, typically motile gametes, especially spermatozoa • Male-to-female (transgender woman): Someone with a female gender identity and a male assigned sex at birth • Transgender (gender non-confirming): Someone whose Gender Identity differs from the sex they were assigned at birth https://transcare.ucsf.edu/guidelines/terminology Outline • Part 1: Discuss the menstrual cycleè reviewed prior to class • Part 2: Contraceptives • Non-hormonal • Hormonal • Emergency contraceptives • Part 3: Selecting the correct contraceptive for your patient • Design a case!!! Part 2: Contraceptives Contraceptives Non-hormonal Fertility awareness method/ withdrawal method Spermicides Barriers Hormonal Copper IUD Condoms, sponge, cervical cap, diaphragm Sterilization/ vasectomy Pills, patch, vaginal ring, vaginal systems, injectables, implants, hormonal IUD, emergency contraceptive Efficacy General Information about Contraception • No birth control method is 100% effective • • Simultaneous use of 2 methods improves efficacy Any studied method used correctly is better than none Sexually active women should have access to reliable contraception • Women should know risks & benefits • Education provided in an unbiased manner should help women to find a method aligns with their personal needs & preferences • Contraceptive counseling optimally also includes STI information • “Safe sex” methods should be addressed • Emergency contraception should be discussed and made available to everyone women seeking contraception • Which of the following is in order of efficacy (most>least)? A. B. C. D. Oral contraceptive > condom > IUD Vasectomy > hormonal patch > withdrawal method Spermicide > condom > diaphragm IUD > spermicide > condom No one method of contraception is 100% effective, except for abstinence. A. True B. False Non-hormonal Contraceptives Fertility awareness method The basics v “Natural family planning” or “rhythm method” v Prediction of fertile and infertile time in the female cycle v Up to a 25% failure rate, resulting in pregnancy Assumptions • • • • An egg is released once in each menstrual cycle The egg lives 12 to 24 hours Sperm can live up to 5 to 6 days A woman is fertile for as long as 6 days before ovulation and 2-3 days after (up to 8 days of fertility per cycle each month) Fertility awareness method Types Calendar method • Track menstrual cycle for several months • Mark first day of your period = day 1, then mark the first day of your next period • Count total number of days between each cycle • Cycle MUST be ≥ 27 days • Fertile 18 days before time of shortest cycle and 11 days before longest (days 10-17 in 28-day cycle) This is confusing…let’s do an example! First Day of Period 5 19 # Days in Cycle January 20 29 February 18 29 March 18 29 April 16 29 May 12 27 June 9 28 July 9 30 August 5 28 6 7 1 2 8 9 To predict the FIRST fertile day: 1. Find the shortest cycle = 27 days 2. Subtract 18 from the total = day 9 3. Count day 1 as the start of your period. 3 To predict the LAST fertile day: 4 1. Find the longest cycle = 30 days = Start of period = Fertile days = Safe days 2. Subtract 11 from the total = day 19 3. Count day 1 as the start of your period. Fertility awareness method Types Standard days method (cycle beads) • Like the calendar method • You track your menstrual cycle for several months • Determine cycle length 26 and 32 days long — you can’t use this method if it’s longer or shorter. • Use another form of birth control on days 8-19, which is when you’re fertile. • Can download the app or use the CycleBeads • • • If using the beads, start with the rubber ring on the red bead (first day of the menstrual cycle) Each day the rubber ring is moved over to the next bead White beads indicate when pregnancy is MOST likely Fertility awareness method Types • Basal body temperature • Take your temperature the same way every day, prior to getting out of bed and document • Body temperature is typically lower in the first part of the cycle and then rises when you ovulate • Cervical mucus • No mucus = safe (dry days) • Mucus increases as the egg starts to ripen and before ovulation (slippery days); mucus may resemble raw egg whites Fertility awareness method Pros and cons PROS Inexpensive Natural No adverse drug events May be combined with other methods o Consistent with some religious belief systems o o o o o o o o CONS Moderate failure rates (12-24 % failure) Requires regular cycles, education and motivation Long periods of abstinence required NO STD protection Which of the following is incorrect regarding the fertility awareness method? A. B. C. D. It predicts the fertile and infertile times during the month An egg can live up to 6 days It has up to 25% failure rate It is also known as the “rhythm method” Withdrawal method The basics • “Pull out method” • This method prevents semen from entering the vagina, which would increase the chance of pregnancy • NO STD protection • Most effective with other types of birth control (pill, condoms, ring, etc.) • On average on 78% effective, when done correctly each time The “withdrawal” method provides STD protection. A. True B. False Spermicides The basics • Works by blocking the entrance to the cervix (sperm cannot reach the egg) and keeps sperm from being mobile and swimming to the egg • Active ingredients include: nonoxynol-9, octoxynol-9 (off the market in 2002), menfegol (Europe only) • Many forms: creams, foams, gels, suppositories, tablets and films Spermicides Usage Considerations • NO STD protection and may INCREASE risk of transmission of HIV with regular use • Must be inserted deeply in the vagina 10-30 minutes prior to sex • Foams are the most effective (highest nonoxynol-9 content) • Jellies may be less effective due to uneven spread • About 72% effective in preventing pregnancy PROS CONS Easily accessible and available OTC Messy, interferes with spontaneity Additional lubrication May increase STD transmission due to vaginal mucosal irritation Barriers The basics • Effectiveness depends on motivation to use them consistently and correctly • 72-88% effective in preventing pregnancy with typical use • Many used in combination • Examples: condoms, diaphragm (with spermicide), cervical cap and sponge Barriers Condoms - male • 82% effective in preventing pregnancy • Create a mechanical barrier • Prevent direct contact of vagina with semen, genital lesions and infectious secretions • Most are made from latex=> impermeable to viruses • Many different types: • Latex versus animal membrane (no STI protection) versus polyurethane • Plain versus reservoir tip • Dry versus lubricated Barriers Condoms - male Counseling Points • Do NOT use petroleum jelly, lotions, or oil-based vaginal drug formulations or lubricants • Do NOT store in extreme heat • NOT recommended to use with spermicides because may increase risk of HIV, with no additional protection PROS CONS Easily accessible and available OTC High user failure rate & possibility of breakage Inexpensive Poor acceptance STD protection (latex) Possible allergic reaction to latex Barriers Condoms - female • • • • • 79% effective in preventing pregnancy Loose-fitting polyurethane sheath Closed at one end with flexible rings at both ends Inserted intra-vaginally Contra-indicated with a history of toxic shock syndrome Barriers Condoms - female Counseling Points • • • • • Insertion outside of device may occur during intercourse Can be inserted in advance Recommended for a one-time use Discard in garbage Available through distributors and from “The Female Health Company” PROS CONS Gives women control over condom use More expensive than male condoms Hormone and latex free Aesthetically less acceptable STD protection; and may provide better HSV/HPV protection, as well as Zika virus Higher pregnancy rate compared to male condoms Barriers Sponge • • • • • Inserted intra-vaginally Protection for 24 hours Left in for at least 6 hours after intercourse A new sponge is not required for multiple acts of intercourse Contraindicated with a history of toxic shock syndrome Barriers Sponge • 68*- 88% effective in preventing pregnancy • The sponge contains a spermicide • Concave dimple on one side that fits over the cervix and a loop on the other side • Can be used WITH a condom PROS * CONS Easily accessible and available OTC NO STD protection Inexpensive May be hard to use correctly Women who have given birth Barriers Cervical cap • Small cup made from soft silicone, shaped like a sailor's hat • Inserted intravaginally and covers the cervix • Must be used with a spermicide • Must be prescribed by a physician • Can be inserted before intercourse Barriers Cervical cap • 71* – 86% effective when used correctly • Keep in place at least 6 hours after intercourse • Held in place by suction • Changes in our body over time can alter the fit of the cervical cap PROS Re-usable and portable Up to $225 cost Hormone free Does NOT prevent STDs Effective immediately * CONS Women who have given birth Barriers Diaphragm • Shallow cup shaped like a saucer, made of soft silicone • Inserted intravaginally and covers the cervix • Must be used with a spermicide • Must be prescribed by a physician • Can be inserted before intercourse Barriers Diaphragm • 88% efficacy when used correctly • Changes in our body over time can alter the fit of the diaphragm • Can be inserted up to 2 hours prior to intercourse • Must be left in place for at least 6 hours after intercourse PROS CONS Re-usable and portable Up to $250 cost Hormone free Does NOT prevent STDs Effective immediately Which of the following are considered barrier contraceptives? A. B. C. D. Diaphragms Condoms Cervical caps All of the above Copper IUD • More than 99.9% effective to prevent pregnancy after unprotected sex (when inserted within 120 hours (5 days) • It’s the most effective way to prevent pregnancy after sex • More risks of infection/uterine perforation than post-coital hormonal options • Works by changing sperm motility, so it cannot make it to the egg for fertilization Copper IUD • • • • Make periods heavier and cramps worse Placement may cause some temporary discomfort Replacement required every 12 years Once an IUD is placed, a string about 1 or 2 inches long will come out of your cervix and into the top of the vagina PROS CONS Nearly 100% effective Up to $1300 cost Hormone free Does NOT prevent STDs Effective immediately Must be placed by a prescriber Copper IUD Contraindications/warnings: • • • • • Have certain STDs or pelvic infection Think you might be pregnant Have cervical cancer that hasn't been treated Have cancer of the uterus Have had a pelvic infection after either childbirth or an abortion in the past 3 months Sterilization • The most widely used occlusion methods are typically performed on the isthmic portion of the fallopian tube: • Partial salpingectomy • Clips • Silicone rings • Electrocoagulation • Micro-insert Sterilization Micro-Insert Tubal Occlusion (Essure ) ® • FDA approval in November 2002 • First of FDA approved hysteroscopic method of tubal sterilization available • Placement of micro-inserts into proximal fallopian tubes • • • 99% effective 30 minutes in trained doctor’s office No incisions or general anesthesia required • Back up contraception for 3 months Sterilization Tubal Occlusion Method: (Adiana™) • Under hysteroscopic guidance, a catheter is introduced into the tube, once placement is confirmed, then the catheter delivers radiofrequency energy for a period of 1 minute, causing a lesion • Once this is complete, then a silicone matrix is placed within the lesion. • Occlusion of tubes must be assessed by HSG 3 months after the procedure Sterilization Vasectomy A couple of stiches placed Area cauterized Incisions made to the vas deferens PROS CONS Highly effective Regret, may not be readily reversible One time decision Does NOT prevent STDs Few side effects Risk of ectopic pregnancy Which of the following about sterilization is true? A. B. C. D. It has many side effects STDs are no longer a concern Regret may occur as it may not be readily reversible It is associated with a decrease rate of ectopic pregnancy Take 1 minute to think about and write down the big take away points from the Non-Hormonal Contraceptive Section. Take 1 minute to turn to your partner and tell your partner what your take away points are. While one partner is sharing their information, the other partner should listen. Switch roles and take 1 minute to share and tell your partner about your take away points. While one partner is sharing their information, the other partner should listen. With your partner, take 2 minutes to add main points into the Canvas discussion board. Hormonal Contraceptives Hormonal Contraceptives Oral • Combined estrogen and progesterone (cOCP) • Progestin only (POP) Injectable • Depo-Provera® Vaginal • NuvaRing® Vaginal System • Annovera® Transdermal • OrthoEvra® Intrauterine • Mirena® • Skyla • Liletta Implantable • Nexplanon™ Emergency Contraception • Plan B® Combined OCPs– Mechanism of action • Inhibition of ovulation thru combined action of progestin and estrogen • Progestin is the dominant component • Inhibits ovulation (60-80-%) via suppression of cyclical release of LH from the anterior pituitary • Secondary MOA: secretes thick cervical mucus (slows sperm transport) and inhibits capacitation (activation of enzymes that permit ovum penetration) • Estrogen also inhibits ovulation • Suppresses release of FSH (primarily) and LH, which leads to blunting of follicular growth What do hormones look like on a combined OCP??? How are combined OCPs designed??? ESTROGEN PROGESTINS • Ethinyl Estradiol (EE) is the most common • Mestanol was one of the first synthetic estrogens made=> converted to EE in the liver • Synthetic progestins are derived from testosterone or progesterone • Drospirenone is a 4th generation progestin and the least androgenic Contraceptive Evolution 1960s 2 3 t if rs ch ed pat v ro ive p ap ept A ac D F ntr co Tr i AN pha D sic 1 st O pr CPs og a pi es va ll tin ila -o ble nl y al r do e ov ive r p t ap cep sic] DA tra pha F st con ono r i F [M 19 OC 76 – Ps Bi av ph ail as ab ic le 1 1980s 1970s 2003 2019 al ant n o pl m r im o h ive t t s r p i e F ac tr n co cle l y -c na d e mo d en hor ing t ex ND al r t s n Fir CP A agi O v 2002 a n i ag “ v “ m t e s Fir syst 2006 Contraceptive Evolution 1960s 2 3 t if rs ch ed pat v ro ive p ap ept A ac D F ntr co 1970s 2019 al ant n o pl m r im o h ive t t s r p i e F ac tr n co Sum m Firs er 20 t OT 23 C or al c o nt le c y Tr i AN pha D sic 1 st O pr CPs og a pi es va ll tin ila -o ble nl y al r do e ov ive r p t ap cep sic] DA tra pha F st con ono r i F [M 19 OC 76 – Ps Bi av ph ail as ab ic le 1 1980s 2003 c nal ed mo d en hor ing t ex ND al r t s n Fir CP A agi O v 2002 2006 race a n i ag “ v “ m t e s Fir syst ptiv e Classification of progestins Formulation types of combined OCPs Monophasic (fixed estrogen and progestin on active days) v ON 1/35, DEMULEN, NORDETTE Biphasic (decreased progestin:estrogen ratio first 1/2 of cycle for proliferation) v ON 10/11, NELOVA 10/11 Triphasic (estrogen remains same or varies, progestin fixed or varies) v ON 7/7/7, TRI-NORINYL, TRIPHASIL, ESTROSTEP, ORTHO TRICYCLEN **NO ROUTINE ADVANTAGE OF BI-, TRIPHASIC** However…combined OCPs have evolved • Pills were being designed to be 24 days with active drug and 4 of placebo (versus 21/7) • Goal was to decrease flow and for a shorter duration • Examples: YAZ-20 mcg EE + 3 mg DPN and Loestrin 24 FE 20 mcg EE + 1 mg NTE (4 placebos are brown iron tablets) • Just as effective as 21/7 regimens • Bleeding often continues into the start of the next pack **Counseling point** • Experts agree that having a monthly period while on the pill is not needed for safety reasons (i.e., to decrease risk of endometrial cancer) because there are no physiologic changes to prepare for pregnancy in women taking OCPs Extended cycle combined OCPs • 1st approach was the 84/7 - 4 periods/year • • 30 mcg EE and 150 mcg LNG (SEASONALE) x 84 pills + 7 placebos SEASONIQUE is the same hormonal content for 84 days as above but provides 10 mcg EE instead of 7 placebos • As safe and effective as traditional 21/7 day regimens • More bleeding irregularities (break thru bleeding, spotting) • Average 12 days during 1st cycle, <4 days by 4th cycle • Seasonique designed to decrease this issue, but it doesn’t appear that low dose EE x 7 days impacts this • Most important counseling point Finally…continuous cycle combined ocp • • • • Continuous hormones without placebos or dose reductions 20 mcg EE+ 90 mcg LNG Appears as effective as 21/7 regimens & no differences in safety 60%-80% of women experience complete amenorrhea (but still some spotting) • Most common adverse event is break thru bleeding, particularly in 1st 3-6 months • Only 20% experience spotting by pack 13 (after 1 year) • Women should be counseled to expect bleeding irregularities x 3-6 months • Weigh potential convenience of amenorrhea after 1 year with early BTB inconvenience Take home points about extended/continuous cycle combined OCPs • Greatest issue is tolerability due to BTB • 20%-50% d/c rates related to bleeding • Keep in mind this is one of primary reasons women discontinue w/ 21/7 regimens in 1st 3-6 months also • Endometrial biopsies after 1 year show no pathologic changes – no need to do biopsies • Return to fertility not a concern – • Extended cycle women have withdraw bleeds every 3 months • 90% of continuous cycle women have a period within 3 months of discontinuing • Pregnancy – • Other signs present: morning sickness, breast tenderness, fatigue, increased sensitivity to smell • No evidence that hormonal exposure to fetus has detrimental effects Combined OCPs– Pros • Excellent reversible contraception • Reduction in ovarian, endometrial cancer (50%) • Reduction in colon cancer (18% - 40%) • Decrease in benign breast disease • Decrease in pelvic inflammatory disease (PID) (50%) - may decrease tubal pregnancy • Fewer functional ovarian cysts • • • • Cycle control (decreased migraine +/-) PMS and dysmenorrhea reduction Iron deficiency and toxic shock reduction Acne reduction +/- (depends on progestin component) • Increased bone mineral density (25% fewer hip fx) Combined OCPs - Cons Thrombosis: • A - Abdominal pain (severe) • C - Chest pain (severe), cough, SOB • H - Headache (severe, new, different), dizziness, weakness, numbness (especially if 1 sided) • E - Eye Problems (vision loss or blurring) • S - Severe leg pain (calf or thigh) or swelling Combined OCPs - Cons • Venous thromboembolism (VTE) • Non pregnant no COC • COC user • Pregnant woman • • • • • 0.4-1.1 1.0-3.0 5.9 Deep vein thrombosis (DVT) Pulmonary embolism (PE) Gallbladder disease Stroke Myocardial infarction (MI) More common in: high-dose formulations & newer progestins & patch R e c a p Combined OCPs—absolute contraindications • Thromboembolic disorders • Known or suspected estrogen-dependent cancer • Undiagnosed abnormal vaginal bleeding or breast lumps (cOCPs only contraindicated in women with a history of breast cancer) • Known or suspected pregnancy • Acute liver disease / impaired function • Active gall bladder disease • CHD, CVD, PVD or valvular heart disease • SMOKER > 15 cigs/day Combined OCPs—relative contraindications • Vascular or migraine HA The G • HTN (not controlled or > 35 y/o) R AY • Planned surgery or casting of lower legs • Age > 35 years with CHD risk factors? • Previous cholestasis during pregnancy • Diabetes with microvascular disease or > 20 years duration? • Any smokers?? • Poor ability to comply daily Zone Combined OCPs—minor side effects • Breakthrough bleeding - #1 reason for discontinuation • Amenorrhea - try increased estrogen or lower progestin • Breast tenderness - try lower estrogen • Nausea/vomiting - take with food or at bedtime; try a lower estrogen • Menstrual Migraines - increasing the time between “pill-free” (placebo) intervals Which of the following is NOT true regarding combined-OCPs? A. They are associated with an increased risk of ovarian and endometrial cancers B. Extended cycle cOCPs are just as effective as the 21/7 cOCPs C. It is rare for a healthy young woman to develop a VTE D. cOCPs are contraindicated in 1 pack per day smokers How to select and start a combined OCP 1. Review history: contraindications &/or compliance concerns? 2. Previous OCP failure? • (Consider advantages of other methods for individual) 3. Less androgenic progestin? 4. 35 mcg or less of ethinyl estradiol? 5. Avoid LNG if CHD risk or DM 6. Only low dose (< 35 mcg EE) for smoker 7. Sensitivity profile 8. Looking for fewer/no periods? Quick Start Initiation Method Historically recommended to start around menstruation; however this method has fallen out of favor and thought to be the cause of unintended pregnancies Women tested for pregnancy in office If negative provided a starter pack or Rx for cOCP to start that same day Evidence suggests increased adherence rates at 3 months vs traditional initiation schemes Use backup method x 7 days No difference in menstrual irregularities in first few months Some recommend 3 weeks if cOCP initiated more than 5 days after menses because of unpredictability of ovulation Conflicting info on long term (3-6 months) compliance rates or pregnancy prevention Important Patient Education Points 1. Purpose of therapy & benefits 2. Initiation schemes 3. Active vs Inactive Pills (Packaging) 4. What to do if a dose is missed 5. Drug interactions 6. Self limiting side effects - BTB, spotting, nausea 7. Side effects that require immediate attention ACHES 8. No barrier to STDs 9. Return of fertility Missed Doses One Tablet Two Tablets* Three Tablets* Combined OCPs Progestin- only Take ASAP or 2 the next day ASAP, next at regular time** Take 1 tab BID x 2 days 1 of missed, discard other Begin new pack 7 days after last taken tab D/C until pregnancy r/o *Use backup x 7 days; **if > 3 hours late, use backup x 2 days Drug Interactions Hepatic enzyme inducers • Anticonvulsants • phenytoin, phenobarbital, carbamazepine, felbamate, topiramate • Antibiotics • rifampin, griseofulvin • St. John’s Wort Sign of decreased hormone concentrations may be breakthrough bleeding, during monthly pills Is the pill just right??? Estrogen Excess Estrogen Deficient Progestin Excess Progestin Deficient Nausea/Vomiting Early cycle spotting (days1-9) Hunger and weight gain Late cycle spotting Depression/fatigue Heavy flow/clots Light/no periods Delayed withdrawal bleeding Bloating/Edema Hypertension Vasomotor symptoms Migraine Very Light or NO period Rash/pruritis Cyclic Weight Gain Nervousness Breast tenderness *related to the androgenicity of the progestin Acne/oily skin* Hair loss/hirsutism* Marie is a 21y.o. who was started on an oral contraceptive for the first time 3 months ago. Since she has been taking the pill, she has noticed that she has been having breakouts like never before, and has gained 7lbs, which she thinks is likely due to her increased appetite and poor diet. What is the most appropriate information you can provide her? A. She is experiencing an excess of estrogen, and she should be switched to DMPA injection. B. She is experiencing a deficit of estrogen, and should be switched to a first generation cOCP. C. She is experiencing a excess of progestin, and would likely benefit from a less androgenic progestin. D. She is experiencing a deficit of progestin, and would do well on Yaz. Take 1 minute to think about and write down the big take away points from the combined oral contraceptives section. Take 1 minute to turn to your partner and tell your partner what your take away points are. While one partner is sharing their information, the other partner should listen. Switch roles and take 1 minute to share and tell your partner about your take away points. While one partner is sharing their information, the other partner should listen. With your partner, take 2 minutes to add main points into the Canvas discussion board. Use of combined OCPs in special populations v Women (>40 years) v Obesity v Post-partum v Breastfeeding Women (>40 years) • Up to 80% of women 40-43 years of age can get pregnant • Most women are perimenopausal • Decreased fertility, but 2nd greatest time for unintended pregnancy (38%) • Data limited on safety • Case-control studies showed MI and stroke risk in users are similar to non-users and no increased risk of breast cancer • Benefits: • Increased bone mineral density and decreased vasomotor events (VME) AND pregnancy prevention • Use individualized • Option if women otherwise healthy & no significant risk factors (HTN, dyslipidemia, smoking) • ACOG suggests that cOCPs can be continued to age 50-55 years of age in healthy women Obesity • Increasing obesity in US • Association between increased body weight (BMI) and contraceptive failure with the patch, and emerging data with cOCPs • 1 study reported 60% and 70% higher unintended pregnancies in women > 27.3 and 32.2 kg/m2, respectively vs women w/ lower BMI, accounting for 2-4 pregnancies per 100 woman year of use (low absolute increase) • Hypothesized that women w/ increased body weight have increased BMR and induction of hepatic enzymes • Increased hormonal clearance and decreased serum concentrations • More fat tissue leading to hormonal sequestration and decreased free hormonal serum concentrations • ACOG acknowledges that this may be an issue but supports use of OCPs in obese women given their rates of unintended pregnancies are still low BMR: Basal metabolic rate Post-partum Immediately postpartum there is increased risk of VTE • • • Hypercoagulability decreases by 3 weeks postpartum It is recommended to start cOCPs 3-4 weeks POST-PARTUM if not breastfeeding Alternative options: • • • Use progestin only pills DMPA in interim if warranted Long acting progestin IUD or implant DMPA: depot medroxyprogestrone acetate Breastfeeding • Estrogen can inhibit prolactin and have negative effects on milk flow • Thus progestin-only methods are preferred because they do not affect milk production or have known effects on infant development • ACOG and other experts suggest that cOCPs may be used after 6 weeks of lactation in women with well-established milk production With your partner, take 2 minutes to add main points into the Canvas discussion board about the cOCPs in special populations. Progestin only pill • MOA: Suppression of ovulation, changes in cervical mucus and sperm capacitation • Failure rate: 0.5% (optimal), 2% (typical) • Taken at the same time daily to be effective • Use of a secondary method for 1st 2 months is needed • Candidates: lactation, contraindications to estrogen containing cOCPs • Adverse Effects: irregular bleeding A Breastfeeding woman who wishes to be started on a contraceptive would benefit most from a progestin only pill. A. True B. False Injectable hormones Depo- Provera (DMPA) • Aqueous suspension of MPA microcrystals provide 34 months blood levels • 150 mg admin IM to gluteus or deltoid q 3 months or 104 mg SC (only in office) • Initiated within 5 days of menses or post-partum (PI says after 6 weeks in lactation) Comparable to “implants” or sterilization Not affected by weight or drug interactions • Ovulation does not occur for 14 weeks • Median time to conception - 10 months • Menstrual changes in all women (EDUCATE) • Unpredictable spotting that will decrease over time • Amenorrhea in 50% after 1 year, and 70% after 2 years • Most frequent cause for dissatisfaction and D/C Injectable hormones PROS • Increased hemoglobin levels (amenorrhea) • Less compliance problems & nausea than OCPs • Privacy of use • No increased thromboembolism risk • Highly efficacious • No neoplastic risk (some endometrial protection & no breast cancer risk) • Low cost CONS • • • • Weight gain (~2-7 lbs) Impaired glucose tolerance Headache, dizziness, bloating Extended time until fertility return • up to 18 months for most women to conceive • Reversible decrease in BMD (menopausal estrogen levels) 3%-7% with no increase in fractures • Recent study shows return to expected BMD after 1 year (similar to breast feeding) Vaginal ring NUVARING • Soft, flexible 2” vaginal ring • Releases small daily doses of etonogestrel 120 mcg/day (active metabolite of desogestrel) and EE 15 mcg/day over 21 days • Provides month long contraception • Inserted and remains in place for 3 weeks • Remove for 1-week break during which hormone withdraw bleed usually occurs on day 2-3 after removal • Now available as a generic!! * ENG EE Tmax* Cmax+ Tmax* Cmax+ Ring 200 1716 59 33 Oral 1.3 4273 1.2 125 hours + pg/ml Vaginal ring—NuvaRing INITIATION & PATIENT EDUCATON • If not on previous contraceptive, use 7 days of back-up method • May insert anytime up to 7 days after last cOCP – no backup needed • If initiating after a progestin-only method – use back-up x 7 days • If ring comes out, rinse with cool to lukewarm water and reinsert – use backup contraceptive if out >3 hours • If left in for >3 weeks, remove and have 1 week ring-free interval; new insertion day • Rule out pregnancy if in for >4 weeks • If missed menstrual period and ring was in place all month, then no need to test until miss second period Vaginal ring—NuvaRing® PATIENT EDUCATION • Insert on or prior to day 5 of menses, even if bleeding is still occurring • To insert, squeeze ring between your thumb and index finger and gently insert into vagina • If you feel the ring, simply slide the contraceptive ring farther into your vagina. The exact position is not important for it to work and the muscles of your vagina should keep NuvaRing® securely in place. • To remove: simply put your finger into your vagina and pull NuvaRing® out Vaginal ring—NuvaRing® Reasons for Discontinuation Vaginal symptoms 3.4 % Headache 1.3 % 50% less EE systemic exposure vs cOCPs Mood change 1.2 % • Compliance–not having to remember to use • Privacy? Weight gain 1.0 % Bleeding 0.8 % Pregnancy 0.3 – 1.5 % Other 13.4 – 23.4 % Total 29.6 – 41.0 % Advantages • Fewer systemic hormonal side effects • Disadvantages • Local complaints 2.5-4.4% (foreign body sensation, coital problems, vaginitis) Vaginal System ANNOVERA • Made of silicone and not natural rubber latex • Releases daily doses of ethinyl estradiol (0.013 mg/day) and includes a new progestin called segesterone acetate (0.15 mg/day); while inserted for 1 year (assumes it is removed 7 days per cycle) • Provides month long contraception • Inserted and remains in place for 3 weeks • Remove for 1-week break during which hormone withdraw bleed usually occurs on day 2-3 after removal • The system is rinsed, and stored, then reinserted at the start of the next cycle (7 days later) Vaginal System—Annovera INITIATION & PATIENT EDUCATON • If not on previous hormonal contraceptive, insert between days 2 and 5 of regular menstrual bleeding • If switching from a cOCP, may switch on any day • If initiating after a progestin-only method – use back-up x 7 days • If ring comes out, rinse with cool to lukewarm water and reinsert – use backup contraceptive if out > 3 hours • Should not be used unless > 4 weeks post-partum and NOT breastfeeding • If ring comes out, replace by 2 hours, or use back-up methods for 7 days Vaginal System—Annovera PATIENT EDUCATION • Insert vaginally; vaginal system should remain in the vagina continuously for 21 days (3 complete weeks), then removed for 1 week (during this time a withdrawal bleed usually occurs) • The day and time of insertion should be noted so that the vaginal system can be removed 3 weeks later on the same day and at about the same time • The system should be cleaned with mild soap and warm water, patted dry with a clean cloth towel, and placed in its case during the 1-week dose- free interval; it should be cleaned again prior to reinsertion • Can be used for up to 13 cycles Vaginal System—Annovera Advantages • Fewer systemic hormonal side effects • 50% less EE systemic exposure vs cOCPs • Compliance – not having to remember to use or refill • Prescriber not needed for insertion Disadvantages • Local complaints 2.5-4.4% (foreign body sensation, coital problems, vaginitis) • Has not been adequately studied in females with a BMI >29kg/m2 Transdermal Patch • Ortho Evra – 20cm x 20cm patch • 0.15 mg norelgestromin (active metabolite NGM) • 25 mcg EE released per 24 hours • Supplied in cycles (3 patches) • Single patches (for lost / detached patches) Compliance Comparison Cycle Evra Orthocyclen 1 94% 77% 2 97% 80% 3 97% 78% 4 95% 78% • Pharmaceutic Properties • Matrix-type patch 3 layers: Backing, middle adhesive layer embedded with drug, transparent release liner (protects adhesive during storage) – removed prior to application Transdermal Patch • FDA announced a revision to the label including a new bolded warning: • “A woman on Ortho Evra may be exposed to approximately 60% more estrogen than if she were taking a typical 35 microgram estrogen birth control pill” • “The risk of venous thromboembolic events … may be increased … compared with use of birth control pills. … Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA® compared to women using birth control pills Transdermal Patch 20 cm2 skin patch delivers: 150 mcg norelgestromin (primary active metabolite of 250 mcg norgestimate)/day 25 mcg ethinyl estradiol/day v v v v Apply patch on the arm, abdomen or buttock (not breast)on the same day of the week for 3 consecutive weeks The fourth week is patch-free No restrictions with respect to physical activity Avoid the use of creams, cosmetics or oils around the area of application 1st week 2nd week 3rd week 4th week Transdermal Patch – Patient Education DETACHMENT • For < 1 day: try to reapply in same place or replace w/ new patch immediately; no back-up needed • For > 24 hours or unsure how long: Apply new patch. There is now a new “Day 1” and new patch change day. Use back-up for 1 week • Do not use supplemental adhesives for wraps to hold a “non-sticky” patch in place – use new FORGETTING TO CHANGE PATCH • Up to 48 hours – Apply new patch immediately. Next patch applied on usual patch change day. No backup • Spotting may occur within a couple of days • > 48 hours – Apply new patch and start new 4 week cycle with a new “patch change day”. • Use backup contraception for 1 week • At end of 3rd patch – take it off as soon as remember. Start next cycle on usual “patch change day” – No backup Transdermal Patch PROS v No need for daily compliance v Higher adherence than cOCPs in studies v Comparable efficacy to cOCPs v v v v CONS May be “less private” than cOCP Same as with cOCPs for potential side effects and drug interactions Less effective in women > 198 pounds (90 kg) – not recommended for use Potential skin irritation (9-22%) Hormonal intra-uterine device (IUD) • Highest continuation rates of the reversible • Progesterone/LNG: thickens cervical mucous, inhibits sperm capacitation (LNG 50% inhibition of ovulation by year 1 and to 25% by year 4) • Efficacy similar to female sterilization (0.1% rate unintended pregnancy the first year) v Mirena—20 mcg/day contraception up to 8 years v Liletta—16 mcg/day contraception up to 8 years v Skyla—14 mcg/day contraception up to 3 years v Kyleena—17.5 mcg/day contraception up to 5 years • Prevent union of sperm & egg - primary mechanism • Prevent implantation & growth – secondary mechanism Hormonal IUD • Overall decreased bleeding because LNG acts locally to suppress the endometrium • Associated with delayed or avoided hysterectomy in women w/ bleeding abnormalities • BTB is most common AE, but resolves after 1st 6 months of use for most • Up to 8% will d/c in first yr b/c of bleeding • 20% amenorrheic in 1st year and up to 60% by 5th year with Mirena • Fewer amennorheic with Skyla, Liletta Hormonal IUD Hormonal IUD Absolute Contraindications • Active PID • Known/suspected pregnancy • Uterine abnormalities Relative Contraindications • • • • • • Multiple sexual partners Nulliparous Recurrent pelvic infections/cervicitis Undiagnosed bleeding disorders, anemia h/o ectopic pregnancy Impaired infection response or coagulation WARNING SIGNS P Period late (pregnancy)/spotting A Abdominal Pain or pain during sex I Infection exposure or discharge N Not feeling well: fever, chills S String missing, shorter or longer Hormonal IUD PROS v Reliable, convenient, no compliance issues v No systemic effects (amenorrhea) v Used for prolonged period (cost effective) v Quick return of fertility upon removal CONS v Risk of upper genital tract infection (insertion) v Decreased long-term fertility v Requires medical intervention v Moderate initial expense v Heavier menstrual periods, dysmenorrhea (copper); Irregular bleeding (progesterone/LNG) Implant Nexplanon is a radio-opaque Implanon that uses the active metabolite of desogestrel (etonogestrel), which gives off decreasing amounts of hormone over 3 years • Easier to insert and remove than earlier implants (in providers’ office in 1 min) • Only inserted by those attend manufacturer-sponsored training Suppresses ovulation in 97% of cycles • • • • Thickens cervical mucus Creates atrophic endometrium unsuitable for implantation Efficacy similar to perfect use cOCPs Limited info in women > 130% of IBW Adverse effects v Swelling, irritation and bruising at time of insertion v Irregular menstrual bleeding (18%) v 13%-25% ask for removal the rest year v 22% develop amenorrhea v No effect on BMD Implant-Nexplanon 40 mm 2 mm Core: 40% Ethylene vinyl acetate (EVA) 60% Etonogestrel (68 mg) Rate-controlling membrane: (0.06 mm) 100% EVA Release Rate: 65 – 70 µg/day initially then decreases to 25 – 30 µg/day by end of 3rd year Supplied in a sterile and disposable preloaded applicator Implant PROS v v v v v v Highly efficacious Discreet Long term/non-daily admin No effect on BMD No effect on weight Does not contain estrogen CONS v Irregular bleeding v Insertion and removal procedure v Cost if not intending to use for full 2-3 years Take 1 minute to think about and write down the big take away points from the Hormonal Contraceptive Section. Take 1 minute to turn to your partner and tell your partner what your take away points are. While one partner is sharing their information, the other partner should listen. Switch roles and take 1 minute to share and tell your partner about your take away points. While one partner is sharing their information, the other partner should listen. With your partner, take 2 minutes to add main points into the Canvas discussion board. Newer Contraceptives Phexxi • Hormone free intravaginal gel • Applied prior to intercourse, effective for an hour • Works by altering the vaginal pH • Not effective after intercourse • Requires a prescription • 86% efficacy Phexxi • Most common side effects: • • • • vaginal burning, itching, discomfort yeast infection UTI, bacterial vaginosis vaginal discharge Newer Contraceptives Ovaprene • Hormone free intravaginal device • Inserted and effective for a month • Works by immobilizing sperm • Requires a prescription • 86-91% effectiveness • FDA approved Investigational Device Exemption (IDE) Oct 2022 • Phase 3 study expected to begin mid-2023 Newer Contraceptives Estelle-35ED • 2mg cyproterone acetate and 0.035mg ethinyloestradiol • Can treat androgenic symptoms: acne, PCOS • Estrogen component selectively acts on endometrial tissues=> may result in fewer side effects • Requires a prescription • 98% effectiveness Newer Contraceptives Twirla • Levonorgestrel 120mcg and 30mcg ethinyl estradiol transdermal system • Applied transdermal system similar to the current product on the market, but with a lower estrogen amount • Delayed to market due to skin adherence issues • For women with a BMI <30 kg/m2 • FDA approved Feb 2022 • Requires a prescription • 95% effectiveness Newer Contraceptives Nextstellis • Estetrol (E4) + drospirenone (progestin) • Combined OCP • first and only human estrogen that is sourced from a plant for birth control pills • 98% effective • FDA approved 2021 Newer contraceptives in the pipeline New Contraceptives Undergoing Research • Male contraceptives without the use of hormones à targets protein retinoic acid receptor alpha (RAR-α)/decreases sperm count and is currently under research in mice • Male contraceptive gel with hormones that turns off sperm production • Newer longer acting IUDs that are hormone free and last longer Part 3: Selecting the correct contraceptive for your patient Choice of contraceptive method is ….complicated • Age/maturity level • Reproductive life stage/desire for fertility (long term versus short term) • Marital or relationship status • Culture • Overall health, concurrent medical conditions • Motivation/ability to use method reliably • Male partner involvement in contraceptive choice • Individual sexuality issues • Understanding of anatomy and comfort with body • Number of current sexual partners • Sexual orientation • Lactation status • Perception of various methods and previous experience • Intercourse frequency • Method efficacy • Method cost and availability • Safety factors of each method • Health care access • Non-contraceptive benefits • Convenience The challenge 1. In groups of 8 – 10, write a small case question addressing factors that would affect the choice of contraceptive method. Provide 4 answer choices. 2. Pick a group leader to type up the question and answers. Have the group member submit the case with questions into the discussion board. 3. I will consolidate and post all the questions on canvas and select 3 cases to serve as exam questions. Example of a case question!!! Ellen is a 26 year old, busy mom of two. She just had a baby 4 months ago, is not breastfeeding, and is not looking to have any more children in the near future. She has a history of hypothyroidism, does not smoke or drink (except for when her kids drive her crazy). She admits that with life, she is often forgetful to take her daily vitamin and migraine prophylaxis. Which of the following would you recommend as the best contraceptive option for Ellen? A. Condoms when she remembers to use them B. Nuvaring inserted every 3 weeks C. The progestin only pill daily D. The Today sponge used when needed Questions??? [email protected]