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Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation
Kristina Gemzell-Danielsson1, Regine Sitruk-Ware2, Mitchell D Creinin3
1Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden.
Contraception
|March 5, 2019
Summary
The 1-year segesterone acetate/ethinyl estradiol contraceptive vaginal system (CVS) demonstrates an acceptable safety profile for women seeking long-term birth control. Further research is recommended for obese women due to potential venous thromboembolism risks.
Area of Science:
- Reproductive Health
- Contraception
- Clinical Safety Studies
Background:
- Combination hormonal contraceptives are widely used for birth control.
- New delivery systems for hormonal contraception are being developed to improve user experience and efficacy.
- The segesterone acetate/ethinyl estradiol contraceptive vaginal system (CVS) offers a long-term, user-controlled option.
Purpose of the Study:
- To evaluate the safety outcomes of a 12-month contraceptive vaginal system (CVS) releasing segesterone acetate (SA) and ethinyl estradiol (EE).
- To assess adverse events, expulsions, and specific safety parameters associated with the CVS.
- To compare the safety profile of the CVS with existing combination hormonal contraceptives.
Main Methods:
- Integrated clinical safety data from nine studies involving 3052 women using the CVS.
- Assessed safety through daily adverse event diaries and focused safety studies (endometrial biopsies, vaginal microbiology, liver proteins).
- Analyzed data from studies using the final manufactured CVS, including pharmacokinetic and Phase 3 trials.
Main Results:
- The most common adverse events reported were headache (26%), nausea (18%), vaginal discharge/mycotic infection (10%), and abdominal pain (10%).
- Few women (<1.5%) discontinued use due to adverse events.
- Four women (0.2%) experienced venous thromboembolism (VTE), with three having pre-existing risk factors. Expulsion rates were 19.5% partial and 7% complete per cycle.
Conclusions:
- The 1-year SA/EE CVS exhibits an acceptable safety profile, comparable to other combination hormonal contraceptives.
- The same precautions for prescribing combination hormonal contraceptives should be applied to this new CVS.
- Additional studies are warranted to investigate safety in obese women at higher risk for VTE.
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