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NCT02215395 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Population Council.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target

NCT02215395: Completed Phase 1 study, sponsored by Population Council.

NCT02215395 is a Phase 1 study that has completed, run by Population Council. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02215395, a Phase 1 study, has completed, sponsored by Population Council.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

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).

Primary Outcome

To evaluate adverse reactions to a topical anti-fungal medication when used in conjunction with the NES/EE CVR

Interventions

  • DRUG NES/EE CVR

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2014-03
Est. Completion 2015-04
Phase Phase 1
Population Council

11 total trials

What the finished NCT02215395 record still lists

NCT02215395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 1 intervention - of which NES/EE CVR is the first listed.

NCT02215395 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02215395 about?

NCT02215395 is a clinical study titled "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". 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).

What is the current status of trial NCT02215395?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-03. Estimated completion is 2015-04.

What interventions are being tested in trial NCT02215395?

The interventions under investigation include: NES/EE CVR (DRUG).

Who is sponsoring clinical trial NCT02215395?

This trial is sponsored by Population Council, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02215395's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02215395, the US trial registry maintained by the National Library of Medicine. NCT02215395 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.