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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 77 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01021553
The ClinicalTrials.gov registry entry for NCT01021553 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01021553 reports 0 study locations.
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.
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