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NCT01195974 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.

A Phase 1 study, sponsored by ViiV Healthcare.

Terminated
Registry status
Phase 1
Development phase
13
Enrollment target

NCT01195974 is a Phase 1 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 13 participants.

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The verdict

NCT01195974, a Phase 1 study, was terminated before completion, sponsored by ViiV Healthcare.

TERMINATED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This study is a two-period, double-blind study in healthy adult female subjects. Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods. The length of the Run-in Period will be 28 days or longer, depending on the timing of the subject's menstrual cycle and on whether the subject is taking an OC. Each subject will participate in this run-in period (if needed), followed by two treatment periods. Treatment Periods 1 and 2 must be conducted successively. Subjects will be randomized in a cross-over fashion to either YASMIN with GSK2248761 or Placebo for 10 days and switch GSK2248761 or placebo for another 10 days. Subjects will return to the study center for final follow up evaluations 7 - 14 days after the final dose of study medication.

Interventions

  • OTHER Placebo
  • DRUG GSK2248761
  • DRUG YASMIN

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2010-09-14
Est. Completion 2011-02-09
Phase Phase 1

Sponsor

ViiV Healthcare

182 total trials

What the Registry Record Tells You About NCT01195974

The ClinicalTrials.gov registry entry for NCT01195974 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01195974 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01195974 about?

NCT01195974 is a clinical study titled "A Study to Evaluate the Pharmacokinetics of an Oral Contraceptive When Co-administered With GSK2248761 in Healthy Adult Female Subjects.". This study is a two-period, double-blind study in healthy adult female subjects. Each subject will participate in an oral contraceptive Run-in period prior to the treatment periods. The length of the Run-in Period will be 28 days or longer, depending on the timing of the subject's menstrual cycle an...

What is the current status of trial NCT01195974?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-09-14. Estimated completion is 2011-02-09.

What interventions are being tested in trial NCT01195974?

The interventions under investigation include: Placebo (OTHER), GSK2248761 (DRUG), YASMIN (DRUG).

Who is sponsoring clinical trial NCT01195974?

This trial is sponsored by ViiV Healthcare, which has 182 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.