The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
- Conditions
- Contraception
- Interventions
- Other: Tampon
- Registration Number
- NCT04272008
- Lead Sponsor
- TherapeuticsMD
- Brief Summary
This study will evaluate the effect of Annovera and tampon co-usage on the pharmacokinetics (PK) of segesterone acetate (SA) and ethinyl estradiol (EE).
- Detailed Description
This is an open label, randomized, crossover PK study. Participants will be randomized to one of two treatment sequences. Each treatment sequence consists of two cycles of treatment - one with tampon use and one without tampon use. Tampon use will occur on Days 2 to 5 of contraceptive vaginal system (CVS) use and a new CVS will be used for each treatment cycle. Before starting Annovera use, each subject will use a combined oral contraceptive (COC) for one cycle.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 21
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Annovera with tampon use Segesterone Acetate and Ethinyl Estradiol Annovera with tampon use Annovera (alone) Segesterone Acetate and Ethinyl Estradiol Annovera without tampon use Annovera with tampon use Tampon Annovera with tampon use
- Primary Outcome Measures
Name Time Method The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 3) Days 2 to 3 AUC for 24 hours
- Secondary Outcome Measures
Name Time Method The effect of Annovera and tampon co-use on area-under-the-curve (AUC) of Segesterone acetate and ethinyl estradiol (Days 2 to 5) Days 2 to 5 AUC for 72 hours
Trial Locations
- Locations (2)
Syneos Health
🇨🇦Québec City, Quebec, Canada
University of Pennsylvania Women's Health Clinical Research Center
🇺🇸Philadelphia, Pennsylvania, United States