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NCT01421368 · ClinicalTrials.gov registry record · Phase 1

Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use

A Phase 1 study, sponsored by CONRAD.

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT01421368 is a Phase 1 study that has completed, run by CONRAD. The registered enrollment target is 72 participants.

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The verdict

NCT01421368, a Phase 1 study, has completed, sponsored by CONRAD.

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target

Study Summary

The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.

Interventions

  • DRUG Tenofovir 1% vaginal gel
  • DRUG Depo-medroxyprogesterone acetate (DMPA)
  • DRUG Oral contraceptive: LNG 150 mcg and EE 30 mcg

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2012-03
Est. Completion 2014-03
Phase Phase 1

Sponsor

CONRAD

33 total trials

What the Registry Record Tells You About NCT01421368

The ClinicalTrials.gov registry entry for NCT01421368 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CONRAD, which has 33 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Tenofovir 1% vaginal gel is the first listed.

NCT01421368 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01421368 about?

NCT01421368 is a clinical study titled "Contraception and Menstrual Cycle Effect on Pharmacokinetics, Pharmacodynamics and Safety in Tenofovir Vaginal Gel Use". The purpose of the study is to examine the effects of two contraceptive methods and the menstrual cycle on the pharmacokinetics, pharmacodynamics of tenofovir 1% gel and the effect of the contraceptive methods on markers of mucosal safety.

What is the current status of trial NCT01421368?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2012-03. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01421368?

The interventions under investigation include: Tenofovir 1% vaginal gel (DRUG), Depo-medroxyprogesterone acetate (DMPA) (DRUG), Oral contraceptive: LNG 150 mcg and EE 30 mcg (DRUG).

Who is sponsoring clinical trial NCT01421368?

This trial is sponsored by CONRAD, which has 33 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.