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Annovera™ Drug-Drug Interaction Study

NCT04290390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-01-29

No results posted yet for this study

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

  • Women
  • Contraception

Interventions

DRUG

Segesterone Acetate and Ethinyl Estradiol

Contraceptive Vaginal System

DRUG

Rifampin

CYP3A inducer

DRUG

Itraconazole

CYP3A inhibitor

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
2020-02-12
Primary Completion
2021-01-06
Completion
2021-01-06
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT04290390 on ClinicalTrials.gov