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

NCT04272008 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-10-29

No results posted yet for this study

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).

Conditions

  • Contraception

Interventions

DRUG

Segesterone Acetate and Ethinyl Estradiol

Annovera taken alone

OTHER

Tampon

Annovera with tampon use

Sponsors & Collaborators

  • TherapeuticsMD

    lead INDUSTRY

Principal Investigators

  • Sebastian Mirkin, MD · TherapeuticsMD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2021-06-08
Completion
2021-06-08
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04272008 on ClinicalTrials.gov