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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-09-14 |
| Est. Completion | 2011-02-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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