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Sexual & Reproductive Health (4) Beyaz, Jasmiel, Loryna, Lo-Zumandimin, Nikki, Vestura, Yaz: 4 days of placebo containing levomefolate calcium; approved use for premenstrual dysphoric disorder and acne (5) Nextstellis (estetrol 14.2 mg/drospirenone 3 mg): 4 placebo tablets; may be...

Sexual & Reproductive Health (4) Beyaz, Jasmiel, Loryna, Lo-Zumandimin, Nikki, Vestura, Yaz: 4 days of placebo containing levomefolate calcium; approved use for premenstrual dysphoric disorder and acne (5) Nextstellis (estetrol 14.2 mg/drospirenone 3 mg): 4 placebo tablets; may be less effective in those with a BMI greater than 30 kg/m2. h. Advantages and disadvantages (Table 15) Table 15. Advantages and Disadvantages of COCs Advantages Disadvantages Effective Easy to use Reversible Regular menstrual cycle Reduction of several cancers Decreased risk of benign breast tumors Improves acne Sexual enjoyment Emergency contraception Transition therapy for perimenopause No HIV or STI protection Patient adherence Expensive Adverse effects Circulatory complications Menstrual cycle changes Sexual and psychological effects Hepatocellular adenoma Gallbladder disease Drug interactions COC = combined oral contraceptive (tablet); HIV = human immunodeficiency virus; STI = sexually transmitted infection 2. Transdermal patch (Xulane, Zafemy, Twirla) a. Patch placed on skin; Xulane /Zafemy delivers 150 mcg of norelgestromin/35 mcg ethinyl estradiol (provides 60% more estrogen exposure than 35-mcg oral tablet of ethinyl estradiol); Twirla delivers 120 mcg of levonorgestrel/30 mcg of ethinyl estradiol. b. Effectiveness i. Similar to pills (7% failure rate for typical use, 0.3% for perfect use) ii. Less effective in women weighing more than 198 lb (90 kg); should not be used (Twirla is contraindicated if BMI is 30 kg/m2 or greater) c. Adherence: Better adherence rates than pill, especially in teens d. Counseling i. Proper use (a) Place patch on a dry, hairless area of upper arm, shoulder, abdomen, or buttocks. Should not be placed on the breast. Rotate site of patch each week. (b) One patch per week for 3 weeks; week 4 is patch free (menses will occur then) ii. Adverse effects (a) Higher incidence of blood clots (b) Site irritation from the patch (c) See adverse effects mentioned earlier in text. iii. Missed doses (a) If patch is off for less than 24 hours, reapply patch; no BUM needed. (b) If patch is off for more than 24 hours, open a new patch, new day 1; must use a BUM for first week of the new cycle. iv. Alternative recommendations for missed contraceptive patch application (MMWR Recomm Rep 2016;65:1-66) (a) Missed dose = delayed patch application of less than 48 hours or recommended time for application. (1) Apply new contraceptive patch as soon as possible (if less than 24 hours, may replace same patch). ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-590 Sexual & Reproductive Health (2) Keep contraceptive patch on until scheduled patch change day. (3) No BUM needed (4) In general, EC is unnecessary but may be considered (except for ulipristal) if the patient missed doses earlier in the cycle or in the last week of the cycle. (b) If delayed application is more than 48 hours from scheduled administration time, may recommend the following: (1) Apply new patch as soon as possible. (2) Keep patch on until scheduled patch change day. (3) Use a BUM or avoid intercourse until contraceptive patch has been in place for 7 consecutive days. (4) If doses missed were during days 15–21 of a 28-day cycle (e.g., 3 weeks active hormone, 1 week placebo); then omit the patch-free week and apply a new contraceptive patch. (5) If unable to apply a new patch immediately, use a BUM or avoid intercourse until new patch has been applied for 7 consecutive days. (c) Use EC (except for ulipristal) if active hormone was missed in the first week of the cycle or unprotected intercourse occurred in the previous 5 days. e. Advantages and disadvantages (Table 16) Table 16. Advantages and Disadvantages of Transdermal Contraception Patch Advantages Disadvantages Efficacy Adherence User controlled Readily reversible Site reactions Patch detachment Cost Appearance, less privacy Breast discomfort Dysmenorrhea Headache Nausea Should not be used in women > 90 kg Questionable increased risk of blood clots 3. Vaginal rings a. NuvaRing; EluRyng (other AB-rated products may be available) i. Product inserted vaginally; delivers 15 mcg ethinyl estradiol and 120 mcg etonogestrel (active form of desogestrel) daily. ii.  Effectiveness: Similar to pills (7% failure rate for typical use, 0.3% for perfect use) (Contraceptive Technology, 21st ed. New York: Ardent Media, 2018) iii. Adherence (a) One study found that 92.4% of women using a vaginal ring were adherent versus 75.4% using the COC pill. (b) Users were 96% satisfied; 97% would recommend the ring. iv. Counseling (a) Proper use (1) Insert vaginal ring into vagina and leave for 3 weeks. Week 4, remove and dispose ring and menses will occur. (2) Should not be removed during intercourse. (3) May be worn with tampon if there is breakthrough bleeding. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-591 Sexual & Reproductive Health (b) Missed doses: Inadvertent removal, expulsion, or prolonged ring-free interval (1) If 3 hours or less, rinse with cool to lukewarm water and reinsert as soon as possible. (2) If more than 3 hours, reinsert and use a BUM until ring has been used continuously for 7 days. (c) Alternative recommendations for missed vaginal ring insertion (MMWR Recomm Rep 2016;65:1-66) (1) Missed dose = delayed insertion of less than 48 hours or recommended time for insertion (A) Insert new vaginal ring as soon as possible. (B) Keep ring in until scheduled ring removal day. (C) No BUM needed. (D) In general, EC is unnecessary but may be considered (except for ulipristal) if the patient missed doses earlier in the cycle or in the last week of the cycle. (2) If delayed insertion is more than 48 hours from scheduled administration time, may recommend the following: (A) Insert ring as soon as possible. (B) Keep ring in until scheduled ring removal day. (C) Use a BUM or avoid intercourse until vaginal ring has been in place for 7 consecutive days. • If doses missed were during days 15–21 of a 28-day cycle (e.g., 3 weeks active hormone, 1 week placebo); then omit the ring-free week and insert a new vaginal ring. • If unable to insert a new ring immediately, use a BUM or avoid intercourse until new ring has been inserted for 7 consecutive days. (D) Use EC (except for ulipristal) if active hormone was missed in the first week of the cycle or unprotected intercourse occurred in the previous 5 days. (d) Adverse effects (1) Decreased libido (8%) (2) Breast tenderness (4%) (3) Device-related events (2.5%–5%) (4) Vaginal discomfort and secretions (2.5%) (5) Irregular bleeding (1.5%–5%) v. Advantages and disadvantages (Table 17) b. Annovera i. Product inserted vaginally, delivers 0.15 mg/day of segesterone and 13 mcg/day of ethinyl estradiol ii. Effectiveness: 96%–98% effective in preventing pregnancy, has not been studied in women with a BMI greater than 29 kg/m2 iii. Counseling: (a) Proper use (1) Insert vaginal ring into vagina and leave for 3 weeks. Week 4, remove and keep ring and menses will occur. Ring is washed with mild soap and lukewarm water, dried, and stored in the case provided. The same ring is reinserted after 7 days. (2) Should not be removed during intercourse (3) The same vaginal ring is used for 13 cycles (1 year) (4) Does not need to be stored in the refrigerator ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-592 Sexual & Reproductive Health (b) Missed doses: (1) If out 2 hours or less, rinse with warm water and reinsert as soon as possible (2) If out 2 hours or more at one time or out for a time that adds up to more than 2 hours over the 21 days, a backup contraceptive method should be used until the ring has been in place continuously for 7 days (c) Adverse effects (greater than 5%) (1) Headache/migraine (2) Nausea/vomiting/diarrhea (3) Abdominal pain (4) Yeast infections (5) Dysmenorrhea (6) Vaginal discharge (7) Breast tenderness (8) Menstrual irregularities (9) Urinary tract infections (10) Genital itching (d) Drug interactions (1) Similar to those with combined hormonal contraceptives (2)  Increased exposure to hormones occurs with oil-based suppositories such as miconazole 1- or 3-day treatments. Only water-based suppositories should be used concurrently with this vaginal ring. (e) Contraindications – Similar to combined hormonal contraceptives Table 17. Advantages and Disadvantages of Contraceptive Vaginal Ring Advantages Disadvantages Efficacy Adherence User controlled Cycle control Readily reversible Privacy Adverse effects similar to other combined regimens Vaginal discomfort Potential partner awareness of ring 4. Extended regimens (other AB-rated products may be available that are not listed here) a. 3 months: Using active form of combined hormonal contraception for 3 months (results in menses every 3 months instead of once a month) i. Ethinyl estradiol 30 mcg/levonorgestrel 150 mcg, ethinyl estradiol 10-mcg tablets instead of placebo pills (Seasonique, Amethia, Ashlyna, Daysee, Camrese, Jaimiess, Simpesse) ii. Ethinyl estradiol 20 mcg/levonorgestrel 100 mcg, ethinyl estradiol 10-mcg tablets instead of placebo pills (LoSeasonique, Camrese Lo, LoJaimiess) iii. 42 tablets of ethinyl estradiol 20 mcg and levonorgestrel 0.15 mg, 21 tablets of ethinyl estradiol 20 mcg and levonorgestrel 0.15 mg, 21 tablets of ethinyl estradiol 30 mcg and levonorgestrel 0.15 mg, and 7 tablets of ethinyl estradiol 10 mcg instead of placebo pills (Quartette, Rivelsa) iv. 84 tablets levonorgestrel 0.15 mg and ethinyl estradiol 30 mcg (Jolessa, Quasense, Introvale, Iclevia, Setlakin) b. 1 year: Using active form of combined hormonal contraception for 1 year; product: ethinyl estradiol 20 mcg/levonorgestrel 90 mcg (Amethyst, Dolishale) ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-593 Sexual & Reproductive Health VIII. PROGESTIN-ONLY CONTRACEPTIVES A. Indications: Those who cannot use or tolerate combined hormonal contraceptives (see list) or those seeking long-term contraception 1. History of or current MI, stroke, DVT, CVD 2. Atrial fibrillation 3. Blood pressure 160/100 mm Hg 4. Smoker age 35 or older 5. Active, symptomatic liver disease 6. Migraine headache with neurologic impairment or aura 7. Retinopathy or neuropathy because of diabetes 8. Surgery within the past 4 weeks 9. Breastfeeding (estrogen may decrease breastmilk production) B. Components: One of the following progestins 1.  Norethindrone 2. Drospirenone 3. Depot medroxyprogesterone acetate (DMPA) C. Mechanisms of Action 1. Thickens cervical mucus, prevents sperm movement. 2. Thins uterus lining. 3. Suppresses midcycle peak of LH and FSH, inhibits ovulation (minimal with oral progestin pills). D. Contraindications 1. Suspected or demonstrated pregnancy 2. Active hepatitis, hepatic failure, jaundice 3. Inability to absorb sex steroids from GI tract (i.e., active colitis) 4. Concurrently taking medications that increase hepatic clearance (CYP inducers). Note: Medroxyprogesterone acetate okay to use with CYP inducers. 5. Taking an antibiotic such as rifampin or rifabutin (category 3), broad-spectrum antibiotics (category 1). E. Adverse Effects: See progestin adverse effects in Combined Hormonal Contraceptives section earlier in text. F. Types 1. Oral—progestin-only pills (POPs) a. Norethindrone 0.35 mg (“mini-pill”) i. Effectiveness: 7% failure rate (typical), 0.3% failure (perfect use) (Contraceptive Technology, 21st ed. New York: Ardent Media, 2018) ii. Start methods: May start on any day or on first day of period. There are no hormone-free days with the POPs. iii. Adverse effects: Progestin related (see earlier text) iv. Missed doses: Doses must be at the SAME time every day; a missed dose means more than 3 hours late to take a dose. If a missed dose occurs, must use a BUM for 48 hours. v. Advantages (a) Efficacy (b) Decreased menstrual blood loss, cramps, pain (c) Readily reversible (d) Preferable in lactating women ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-594 Sexual & Reproductive Health vi. Disadvantages (a) Progestin-related adverse effects (e.g., weight gain, acne) (b) Irregular menses (c) Adherence: Short time window for a missed pill (d) Low-dose progestin; patient may ovulate (e) Fewer noncontraceptive benefits b. Drospirenone 4 mg i. Effectiveness: 98% effective in preventing pregnancy ii. Start methods: Start active tablet on the first day of menses. There are 24 active tablets and 4 inactive tablets. iii. Adverse effects: Acne, metrorrhagia, headache, breast pain or tenderness, weight gain, dysmenorrhea, nausea, vaginal hemorrhage, decreased libido, and irregular bleeding iv. Missed doses: If 1 active tablet is missed, take as soon as possible and finish the pill pack as instructed. If 2 active tablets are missed, take the last missed tablet as soon as possible. Continue taking 1 tablet a day as instructed. Use an additional BUM for 7 days. v. Advantages: Dosing is not as sensitive to timing as for traditional POPs. vi. Disadvantages (a) Progestin-related adverse effects (b) Irregular menses (c) Monitoring of thromboembolism, hyperkalemia, bone loss 2. Depot medroxyprogesterone acetate (DMPA) intramuscular (IM) injection a. A 1-mL crystalline suspension of 150 mg of DMPA injected intramuscularly into deltoid or gluteus maximus muscle every 11–13 weeks b. Effectiveness: Perfect use failure rate: 0.3%; typical use failure rate: 4% (Contraceptive Technology, 21st ed. New York: Ardent Media, 2018) c. Start methods i. Preferred start: First 5 days of menses. No BUM needed. ii. Alternative start: Any time in cycle if not pregnant. Use BUM for 7 days. iii. Postpartum: May give injection before hospital discharge. iv. Breastfeeding: May start immediately or wait 4–6 weeks. v. Switching methods: Any time patient known to be not pregnant. Use BUM if necessary. d. Adverse effects i. Progestin related (see earlier text) ii. Progressive significant weight gain iii. Severe depression (rare) iv. Boxed warning: Loss of bone; women who used DMPA for at least 5 years have significantly reduced BMD of lumbar spine and femoral neck, particularly after 15 years of use and if initiated before age 20. (a) The effect is almost completely reversible, even after 4 years or more of DMPA use. (b) All women placed on DMPA should be taking sufficient calcium and exercising regularly. e. Missed dose: More than 13 weeks between injections. Rule out pregnancy before providing next injection if more than 15 weeks since last dose. f. Patient counseling i. Wait a few hours before massaging area where shot was given. ii. Irregular bleeding or spotting in the beginning that should decrease over time. iii. Take calcium if not achieving 1000–1200 mg/day through diet. iv. Return in 11–13 weeks for next injection. Use BUM if ever more than 13 weeks. v. If ever changing from DMPA to another method, start method when next injection is due. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-595 Sexual & Reproductive Health vi. May have delayed return to fertility for up to 18 months. Use with caution in women 35 years or older who express interest in future conception. 3. DMPA subcutaneously: Subcutaneous injection of 104 mg DMPA, information similar to that stated earlier but, in addition, has FDA indication for endometriosis. IX. INTRAUTERINE DEVICES (IUDs) A. Indications: To prevent pregnancy long term; levonorgestrel IUD is also indicated for heavy menses in women who elect to use an IUD for contraception. B. Recommended for Women Who: 1. Have no history of pelvic inflammatory disease (PID) or ectopic pregnancy 2. Have heavy menses, cramps, anemia, or dysfunctional uterine bleeding 3. Are seeking long-term (2 years or more) pregnancy protection 4. Do not want to use estrogen-containing products C. Types 1. Copper (ParaGard T 380A) a. Copper IUD inserted into the uterus by a health care professional b. Mechanism of action i. Primary action: Spermicidal ii. Copper ions inhibit sperm motility and acrosomal enzyme activation so that sperm seldom reach fallopian tube and are unable to fertilize the ovum. iii. A sterile inflammatory reaction created in endometrium phagocytizes sperm. iv. Does not interfere with ovulation and is not an abortifacient. c.  Effectiveness: Perfect use failure rate: 0.6%; typical use failure rate: 0.8% (Contraceptive Technology, 21st ed. New York: Ardent Media, 2018) d. Contraindications specific to copper IUD i. Pregnancy ii. Women with current or recent (within 3 months) sexually transmitted infection (STI) or woman at risk of STI iii. Uterus less than 6 cm or greater than 9 cm iv. Undiagnosed abnormal vaginal bleeding v. Active cervicitis or active pelvic infection vi. Known symptomatic actinomycosis vii. Recent endometritis (past 3 months) viii. Allergy to copper; Wilson’s disease ix. Uterine distortion or pathology affecting placement x. Known or suspected uterine or cervical cancer xi. Unresolved abnormal Papanicolaou (Pap) test xii. Severe anemia (relative contraindication) ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-596 Sexual & Reproductive Health e. Advantages and disadvantages (Table 18) Table 18. Advantages and Disadvantages of Copper IUD Advantages Disadvantages Efficacy (long term, 10 yr) Adherence Spontaneous sexual activity Readily reversible Cost-effective Patient satisfaction Monthly blood loss increased about 35% Dysmenorrhea Spotting and cramping Expulsion Foreign body Increased risk of infection for 20 days after insertion IUD = intrauterine device. 2. Progestin (levonorgestrel) a. Kyleena: Inserted into uterus by health care professional, stays in for up to 5 years, releases 17.5 mcg levonorgestrel per day for the first year, then 9.8 mcg/day for the second year, and decreases to 7.4 mcg/day by the fifth year; indicated for contraception. b. Liletta: Inserted into uterus by a health care professional; stays in for up to 6 years; releases 18.6 mcg/day initially and declines steadily to 16.3 mcg/day at 1 year, 14.3 mcg/day at 2 years, 12.6 mcg/day at 3 years, and to about 8.6 mcg/day after 6 years; indicated for contraception. c. Mirena: Inserted into uterus by health care professional, stays in for up to 7 years, releases 20 mcg levonorgestrel per day for the first 5 years, 10 mcg/day during the sixth year, and about 8 mcg/day during the seventh year; indicated for contraception and menorrhagia. d. Skyla: Inserted into uterus by a health care professional; stays in for up to 3 years; releases 14 mcg levonorgestrel per day after 24 days, decreasing to 10 mcg/day after 60 days and then to less than 5 mcg after 3 years; indicated for contraception. e. Mechanism of action i. Foreign object in uterus, prevents implantation ii. Progestin thickens cervical mucus, thins endometrium, and inhibits sperm motion. iii. Effectiveness: 99% effective in preventing pregnancy f. Contraindications (package insert) i. Pregnancy or suspicion of pregnancy ii. Congenital or acquired uterine anomaly iii. Acute or history of PID iv. Postpartum endometritis or infected abortion in the past 3 months v. Known or suspected uterine or cervical neoplasia vi. Unresolved abnormal Papanicolaou (Pap) test vii. Genital bleeding of unknown etiology viii. Untreated acute cervicitis or vaginitis ix. Acute liver disease or liver tumor (benign or malignant) x. Woman or partner with several sexual partners xi. Conditions associated with increased susceptibility to infections with microorganisms (e.g., leukemia, acquired immunodeficiency syndrome, intravenous drug abuse) xii. Genital actinomycosis xiii. A previously inserted IUD that has not been removed xiv. Hypersensitivity to any component of this product xv. Known or suspected carcinoma of the breast xvi. History of ectopic pregnancy or condition that would predispose to ectopic pregnancy ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-597 Sexual & Reproductive Health g. Advantages and disadvantages (Table 19) Table 19. Advantages and Disadvantages of Progestin IUD Advantages Disadvantages Efficacy (long term, 3–6 yr) Adherence Menorrhagia improves Spontaneous sexual activity Readily reversible Progestin-related adverse effects Irregular menses (generally for the first 6 mo; then possibly amenorrhea) Expulsion Increased risk of infection first 20 days after insertion Foreign body IUD = intrauterine device. D. Contraceptive CHOICE Project (Clin Obstet Gynecol 2014;5:635-43; N Engl J Med 2014;371:1316-23) 1. Study looked at the use of long-acting reversible contraception (LARC) that included IUDs and implants, followed for 3 years. 2. Women were provided contraceptive of choice at no cost. Women had the choice of pill, patch, vaginal ring, levonorgestrel IUD, copper IUD, or progestin implant. 3. Findings a. LARC methods chosen by 75% of women b. Continuation rates for LARC (implants and IUDs) were higher than for short-acting methods (86% vs. 55% at 12 months and 77% vs. 41% at 24 months). c. Sexual behaviors did not change; 71% of participants reported no change in partners at 6 and 12 months. d. Failure rates for pill, patch, and ring users were higher (4.8%–9.4%) than for LARC users (less than 1%) over the 3 years. e. Those who used shorter-acting birth control methods compared with LARC were 22 times more likely to have an unintended pregnancy. f. Showed safety of LARC use among teens (15–19 years of age). E. Patient Counseling 1. Strings of IUD will be outside the cervix. Patient will be instructed on how and when to check the strings to verify IUD is still inserted correctly. 2. Adverse effects: PAINS a. P: Period late; abnormal spotting or bleeding b. A: Abdominal pain, pain with intercourse c. I: Infection exposure (STI); abnormal vaginal discharge d. N: Not feeling well, fever, chills e. S: String missing, shorter, or longer ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-598 Sexual & Reproductive Health Patient Case 7. L.M., a 37-year-old woman (height 67 inches, weight 95 kg), states that she wants to begin contraception for now; however, she would like to have children in a year or so. Her medical history includes hypertension for 2 years and gastroesophageal reflux disease; she drinks 2 glasses of wine a week and smokes ½ pack of cigarettes/day. Her medications include hydrochlorothiazide 25 mg orally daily, amlodipine 5 mg /benazepril 20 mg orally daily, omeprazole 20 mg orally daily, and occasional ibuprofen. Which contraceptive product is best to recommend for L.M.? A. Transdermal contraceptive patch B. Oral tablet ethinyl estradiol/drospirenone C. Oral tablet norethindrone D. DMPA IM injection X. IMPLANT (NEXPLANON) A. Indication: Long-term prevention of pregnancy for up to 3 years B. Components: Etonogestrel, releases 60–70 mcg/day during weeks 5–6 and then decreases to 35–45 mcg/day by the end of the first year, 30–40 mcg/day after the second year, and 25–30 mcg/day at the end of 3 years. Of note: etonogestrel (Implanon) has been discontinued; only etonogestrel (Nexplanon) is being manufactured and distributed currently. C. Mechanism of Action: A rod inserted in upper arm, 99% effective for up to 3 years, releases progestin etonogestrel, which acts similarly to other progestin-only contraceptives; not tested in women weighing more than 130% of their ideal body weight; may be less effective in overweight women; return to fertility within 1–3 months; Nexplanon is radio-opaque so it is visible on radiograph. D. Adverse Effects 1. Similar to progestin-related adverse effects. 2. Bleeding irregularities 3. Site reactions, inflammation, hematoma, pain, redness at site (3.6%) 4. Difficulty removing rod after 3 years, rod breaks, fibrosis (1.7%) E. Studies (see Contraceptive CHOICE Project under IUD section) XI. LACTIC ACID, CITRIC ACID, AND POTASSIUM BITARTRATE VAGINAL GEL (PHEXXI) A. Single use applicator inserted into the vagina before sex B. Lowers pH of the vagina and decreases the motility or mobility of the sperm. It is not a spermicide. C. Must be used before each session of sex (“1 dose, 1 hour, 1 act”). D. 86–93% effective E. Can be used in combination with other methods, except for the vaginal ring. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-599 Sexual & Reproductive Health F. Benefits: Hormone free, potential for increased sexual satisfaction G. Adverse effects: Vaginal irritation (increased risk with increased frequency of use) XII. EMERGENCY CONTRACEPTION A. Definition: “A therapy used to prevent pregnancy after an unprotected or inadequately protected act of sexual intercourse.” ACOG definition (ACOG Practice Bulletin 152. Obstet Gynecol 2015;126:e1-11) B. Mechanism of Hormonal Methods 1. Inhibits ovulation 2. Prevents fertilization 3. Increases thickness of cervical mucus 4. Prevents implantation (controversial; most recent data suggest this does not occur) 5. Not considered an abortifacient by medical standards; does not disrupt an implanted, fertilized egg. C. Indications 1. Condom broke 2. Misused contraceptive method (e.g., missed a pill, contraceptive patch fell off) 3. Sexual assault 4. Exposure to teratogen 5. Unprotected vaginal intercourse D. Timing: Within 120 hours after unprotected intercourse; package insert for marketed products (levonorgestrel products) states 72 hours, but studies show up to 120 hours may still prevent pregnancy. E. Effectiveness: 57%–85% F. Methods 1. Progestin-only method a. Products: Levonorgestrel 1.5 mg (1 tablet) i. Available over the counter (OTC) for all ages; anyone may purchase. b. Adverse effects i. Nausea: 18%; vomiting: 4% ii. May notice changes in menstrual cycle c. Special populations i. BMI greater than 25 kg/m 2 (a) Progestin-only emergency contraceptive pills are not as effective for those with a BMI of 25 kg/m2 or greater. Either ulipristal acetate (ella) or the copper IUD (Paragard T380A) is recommended for these patients. CDC Medical Eligibility criteria state that hormonal methods of EC may lose effectiveness at a BMI of 30 kg/m2 and higher. (b) Controversial: Because of conflicting and limited data, FDA states that a definitive conclusion is not yet possible regarding the efficacy of levonorgestrel EC in patients with BMI greater than 25 kg/m2; therefore, no change in labeling is currently warranted (www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/planb-consumer-questions-and-answers). (c) The copper IUD is recommended for those with a BMI greater than 35 kg/m2. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-600 Sexual & Reproductive Health ii. Breastfeeding women: All EC methods are category 1 for use according to the CDC Medical Eligibility Criteria; exception: breastfeeding not recommended within 24 hours of taking ulipristal because of high concentrations of ulipristal in milk during first 24 hours, with the highest peak 1–3 hours after administration (breast milk for first 24 hours after administration should be discarded) 2. Ulipristal acetate a. Prescription only b. Progesterone receptor modulator: Binds to progesterone receptor c. Indicated for EC within 120 hours of unprotected intercourse; reported to have 42% more effectiveness in preventing pregnancy than levonorgestrel at 72 hours postcoitus d. Dose = 30 mg orally within 120 hours of unprotected intercourse e. Adverse effects: Headache, nausea, abdominal pain, dysmenorrhea, menstrual changes f. Not approved for use during breastfeeding g. Not recommended for women with a BMI greater than 35 kg/m2, category 2 for women with a BMI of greater than 30 kg/m2; copper IUD is recommended instead h. Use BUM for 7 days after taking ulipristal if using hormonal contraception because ulipristal blocks progesterone receptors. i. Recommended to wait 5 days before initiating or resuming hormonal contraception after taking ulipristal. Starting hormonal contraception before waiting 5 days might alter the effect of ulipristal as well as the effect of hormonal contraception. 3. Copper IUD: May be used within 5 days of unprotected intercourse; requires in-office visit. 4. Levonorgestrel IUD: Shown to be noninferior to copper IUD at preventing pregnancy when inserted within 120 hours of unprotected vaginal intercourse (N Engl J Med 2021;384:335-44). 5. Yuzpe method (not frequently utilized clinically) a. High-dose estrogen plus progestin with dosing obtained using available COC products. b. Adverse effects i. Nausea: 30%–60%; vomiting: 33% with estrogen-containing EC (if vomiting within 2 hours of dose, repeat dose; may take with food or meclizine 50 mg prophylactically 30–60 minutes before each dose) ii. May notice changes in menstrual cycle iii. Breast tenderness, headache XIII. MENSTRUAL DISORDERS (Independent Study) A. Amenorrhea 1. Definitions a. Primary: Absence of menarche by age 16 years with presence of secondary development or age 14 years with absence of secondary development and absence of menarche b. Secondary: Absence of menses for 6 months or three cycles (more common than primary) 2. Causes a. Rule out pregnancy. b. Excessive exercise or low BMI c. Hyperprolactinemia d. Polycystic ovary syndrome (PCOS) e. Unknown ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 1-601