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The Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol

Contraception Clinical Trial

Official title:
A Study to Evaluate the Effects of Annovera™ and Tampon Co-Usage on the Pharmacokinetics of Segesterone Acetate and Ethinyl Estradiol

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04272008
Study type Interventional
Source TherapeuticsMD
Contact
Status Completed
Phase Phase 1
Start date March 6, 2020
Completion date June 8, 2021
View Details
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