What's New in Contraception with Complex Family Planning

Educational Objectives

The goal of this program is to improve the use of contraception in cases of complex family planning. After hearing and assimilating this program, the clinician will be better able to:

1. Optimize the use of combined hormonal contraceptives.
2. Choose an appropriate contraceptive option for preventing pregnancy with minimal adverse events.
3. Compare the various forms of hormonal and nonhormonal contraception available.

Summary

Introduction: norgestrel (Opill, Ovrette) is the first-ever nonprescription daily birth control pill available in the United States; the pill is expected to be more effective than current nonprescription contraceptive methods when used as directed

Need for an over-the-counter (OTC) contraceptive pill: the need to visit a health care provider is a barrier to some people; Grindlay et al (2016) found that ≈33% of respondents who sought hormonal contraception prescriptions encountered various barriers (eg, cost, lack of insurance, appointment challenges, clinician requirements, difficulties accessing pharmacies); the move toward OTC availability aims to address these barriers, particularly for populations facing challenges in health care access; a progestin-only pill containing 0.075 mg of norgestrel (Opill) is available; norgestrel — (approved in 1973 and reintroduced in 2015) has a long history and is known for its efficacy; OTC status is anticipated to enhance accessibility; effectiveness is 98% when used perfectly, translating to a 2% pregnancy rate in 1 yr for users; the pill requires daily intake, ideally at the same time within a 3-hr window, with recommendations for backup contraception if consumed outside this timeframe and no breaks between packs

Annual vaginal ring: the annual vaginal ring (eg, Annovera, Estring, NuvaRing) is a new contraceptive method, similar to the existing ring but designed for year-long usage; the ring, containing segesterone acetate and ethinyl estradiol (E2), offers 98% effectiveness in preventing pregnancy; unlike the traditional ring, it follows a 12-mo system, with the same ring used throughout the year; administration involves 3 wk in and 1 wk out, without the need for refrigeration; adverse events include headaches (≈26%), nausea (18%), vaginal discharge (10%), and abdominal pain (10%); discontinuation rates because of adverse events are low; deep venous thromboembolism risk (a consideration for combined hormonal contraception) has been observed in 0.2% of users, with 75% of them having preexisting risk factors; the ring exhibits the lowest serum concentration of E2 among combined hormonal contraceptives; users have reported good cycle control; focusing on individuals with prior pill or ring use, Griffin et al (2019) observed high satisfaction rates, with >90% satisfaction among former ring users and 97% satisfaction among former pill users; potential continuous use beyond the recommended 3 wk in and 1 wk out has not been extensively studied; while many users may experience spotting after ≈3 mo of continuous use, a brief pause (5−7 days) is recommended to allow the lining to shed before resuming use

Drospirenone (DRSP)-only pill: approved by the US Food and Drugs Administration (FDA) in 2019; this progestin-only pill primarily works through ovulation suppression, distinguishing it from other progestin-only methods that rely heavily on cervical mucus thickening; the 24/4 regimen includes 24 days of DRSP (4 mg) and 4 days of placebo; ovulation suppression is maintained even with missed pills because of its longer half-life of ≈30 hr; while many users achieve amenorrhea, unscheduled bleeding may still occur; this method is particularly suitable for individuals with contraindications to estrogen, eg, postpartum <6 wk, migraines with aura, hypertension; the Medical Eligibility Criteria provides a comprehensive guide for assessing contraceptive safety across various conditions; unscheduled bleeding is any bleeding occurring outside predicted menses; Kaunitz et al (2022) — in a phase 3 trial, ≈40% of users reported some type of unscheduled bleeding by the end of cycle 13, but only ≈3.5% of users discontinued because of unscheduled bleeding

Levonorgestrel and E2 patch (Twirla): approved by the US FDA in February 2020; combines levonorgestrel and E2 in a transdermal system; similar to other existing patches, it is worn for 3 wk followed by 1 wk off; features a lower daily estrogen dose (30 mg compared with the current 35 mg); has 99% effectiveness under perfect use but reduced efficacy for individuals with a higher body mass index (BMI); contraindicated in those with a BMI >30; while there is a standardized recommendation, individualized counseling can explore patient preferences regarding efficacy and method satisfaction

Nonhormonal contraceptive gel (Phexxi): contains lactic acid, citric acid, and potassium bicarbonate; with 86% efficacy during typical use, it is applied around the time of intercourse to modulate vaginal pH; the gel should be used within 1 hr before sex; costs ≈$300 per 12-count box; this method provides an alternative for individuals seeking contraception without hormonal components

DRSP and estetrol (E4) pill (Nextstellis): a new combined oral contraceptive pill containing DRSP and E4, a plant-derived estrogen known for its 4 hydroxy groups); E4 — structurally identical to human estrogen (E) found in the body during pregnancy; unlike some other estrogens, E does not bind to human sex hormone binding globulin, exhibits high oral bioavailability, and has a longer half-life (28−32 hr) than E2; does not interact with cytochrome P450 liver enzymes, reducing the potential for drug interactions commonly associated with oral contraceptives; has negligible impacts on the liver, breast, and vascular endothelium, suggesting potential benefits, particularly in reducing thrombosis risk; may benefit various physiologic systems; with 3 mg of DRSP and a 28-hr half-life, it is 98% effective (based on phase 3 trials); a black box warning is issued for smokers >35 yr of age and those at increased risk for cardiovascular events; although some unscheduled bleeding occurs (≈30% in cycle 1, decreasing to 15%-20% by cycle 13), no thromboembolic events have been reported in efficacy studies

Products in development

Smaller copper intrauterine device (IUD): already approved in some countries; contains 50% less copper than the conventional copper IUD (Paragard); the insertion tube diameter is smaller; Turok et al (2020) — a phase 2 study demonstrated high effectiveness, ease of insertion, and high satisfaction; mean bleeding days per cycle decreased from ≈7 to ≈5; the ongoing phase 3 study, involving ≈1600 patients, is being analyzed, with positive feedback from some participants

Male contraceptive gel: currently in a phase 2B study; combines segesterone acetate (a progestin also used in the new annual vaginal ring) with testosterone to counteract potential decreased libido effects of segesterone acetate; applied on the upper arms and shoulders and absorbed through the skin; decreases sperm production without affecting sexual drive or function; ongoing research aims to establish safety and early data on efficacy before progressing to a phase 3 trial

Nonhormonal method: a novel nonhormonal method for women is in early development, involving vaginal capsules made from biodegradable, nontoxic biopolymer derived from mushrooms or crustacean shells; the substance is used in other FDA-approved medical devices; animal studies demonstrate 100% effectiveness in preventing sperm cell passage, with a subsequent efficacy trial in animals resulting in 0 pregnancies in the treated group vs 8 of 15 in the control group; no human trials have been conducted yet

New IUD (IUB Ballerine): a copper coil; effective for ≤5 yr; approved in ≈30 countries (excluding the United States), with >99% efficacy; incorporates a string for easy extraction

Readings

Cohen M, Edelman A, Bellussi F, et al. Cochrane Review Summaries-April 2021. Obstet Gynecol. 2021;137(4):747-749. doi:10.1097/AOG.0000000000004340; Cohen MA, Kumar S, Hathaway M. Global Preconception and Contraception Care: Using a Life-Course Approach to Improve Health Outcomes in Lower-Resource Settings. Obstet Gynecol Clin North Am. 2022;49(4):647-663. doi:10.1016/j.ogc.2022.07.003; Griffin JB, Ridgeway K, Montgomery E, et al. Vaginal ring acceptability and related preferences among women in low- and middle-income countries: A systematic review and narrative synthesis. PLoS One. 2019;14(11):e0224898. Published 2019 Nov 8. doi:10.1371/journal.pone.0224898; Grimes DA, Lopez LM, Raymond EG, et al. Spermicide used alone for contraception. Cochrane Database Syst Rev. 2013;(9):CD005218. doi:10.1002/14651858.CD005218.pub3; Grindlay K, Grossman D. Prescription Birth Control Access Among U.S. Women at Risk of Unintended Pregnancy. J Womens Health (Larchmt). 2016;25(3):249-254. doi:10.1089/jwh.2015.5312; Jummaat F, Yahya EB, Khalil H P S A, et al. The role of biopolymer-based materials in obstetrics and gynecology applications: A review. Polymers (Basel). 2021;13(4):633. Published 2021 Feb 20. doi:10.3390/polym13040633; Kaunitz AM, Achilles SL, Zatik J, et al. Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women. Contraception. 2022;116:29-36. doi:10.1016/j.contraception.2022.07.010; Turok DK, Nelson AL, Dart C, et al. Efficacy, safety, and tolerability of a new low-dose copper and nitinol intrauterine device: Phase 2 data to 36 months. Obstet Gynecol. 2020;135(4):840-847. doi:10.1097/AOG.0000000000003756.

Disclosures

For this program, members of the faculty and the planning committee reported nothing relevant to disclose.

Acknowledgements

Dr. Kerns was recorded at Obstetrics and Gynecology Update: What Does the Evidence Tell Us?, held Oct 11-13, 2023, in San Francisco, CA, and presented by University of California, San Francisco School of Medicine. For information about upcoming CME activities from this presenter, please visit Meded.ucsf.edu. Audio Digest thanks the speakers and University of California, San Francisco School of Medicine for their cooperation in the production of this program.

CME/CE INFO

Accreditation:

The Audio- Digest Foundation is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The Audio- Digest Foundation designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Audio Digest Foundation is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's (ANCC's) Commission on Accreditation. Audio Digest Foundation designates this activity for 1.00 CE contact hours.

Lecture ID:

OB710202

Expiration:

This CME course qualifies for AMA PRA Category 1 Credits™ for 3 years from the date of publication.

Instructions:

To earn CME/CE credit for this course, you must complete all the following components in the order recommended: (1) Review introductory course content, including Educational Objectives and Faculty/Planner Disclosures; (2) Listen to the audio program and review accompanying learning materials; (3) Complete posttest (only after completing Step 2) and earn a passing score of at least 80%. Taking the course Pretest and completing the Evaluation Survey are strongly recommended (but not mandatory) components of completing this CME/CE course.

Estimated time to complete this CME/CE course:

Approximately 2x the length of the recorded lecture to account for time spent studying accompanying learning materials and completing tests.