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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: Clinical Trial Phase 1 study, sponsored by ViiV Healthcare.
NCT01195974 is a Phase 1 study that was terminated before completion, run by ViiV Healthcare. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT01195974 stopped before completion
NCT01195974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01195974 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01195974's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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