Trials / Completed
CompletedNCT04290390
Annovera™ Drug-Drug Interaction Study
A Drug-Drug Interaction Study to Evaluate the Effects of Strong CYP3A Induction and Inhibition on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol From the Annovera™ Contraceptive Vaginal System
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- TherapeuticsMD · Industry
- Sex
- Female
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
Summary
A Drug-Drug Interaction (DDI) study to evaluate the effects of itraconazole and rifampin on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol from the Annovera Contraceptive Vaginal System (CVS)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Segesterone Acetate and Ethinyl Estradiol | Contraceptive Vaginal System |
| DRUG | Rifampin | CYP3A inducer |
| DRUG | Itraconazole | CYP3A inhibitor |
Timeline
- Start date
- 2020-02-12
- Primary completion
- 2021-01-06
- Completion
- 2021-01-06
- First posted
- 2020-02-28
- Last updated
- 2021-01-29
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04290390. Inclusion in this directory is not an endorsement.