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NCT01021553 · ClinicalTrials.gov registry record · Phase 2
A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT01021553: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01021553 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01021553, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and tolerability of all doses of GSK557296 will be performed as well as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at the end of the 8 weeks of treatment. During the active treatment period study participants will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both 4 week intervals.
Primary Outcome
Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model l
Interventions
- DRUG placebo
- DRUG GSK557296
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2009-12-23 |
| Est. Completion | 2011-05-05 |
| Phase | Phase 2 |
What the finished NCT01021553 record still lists
NCT01021553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01021553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01021553 about?
NCT01021553 is a clinical study titled "A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation". To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men with primary premature ejaculation. An assessment of the safety and to...
What is the current status of trial NCT01021553?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2009-12-23. Estimated completion is 2011-05-05.
What interventions are being tested in trial NCT01021553?
The interventions under investigation include: placebo (DRUG), GSK557296 (DRUG).
Who is sponsoring clinical trial NCT01021553?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01021553's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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