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An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women

NCT02215395 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-08-15

No results posted yet for this study

Summary

To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).

Conditions

  • Antifungal Drug Adverse Reaction

Interventions

DRUG

NES/EE CVR

Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)

Sponsors & Collaborators

  • Population Council

    lead OTHER

Principal Investigators

  • Dennis Morrison, MD · QPS-Biokinetic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

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 NCT02215395 on ClinicalTrials.gov