Trials / Completed
CompletedNCT04272008
The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
A Study to Evaluate the Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- TherapeuticsMD · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Segesterone Acetate and Ethinyl Estradiol | Annovera taken alone |
| OTHER | Tampon | Annovera with tampon use |
Timeline
- Start date
- 2020-03-06
- Primary completion
- 2021-06-08
- Completion
- 2021-06-08
- First posted
- 2020-02-17
- Last updated
- 2021-10-29
Locations
2 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04272008. Inclusion in this directory is not an endorsement.