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NCT00644631 · ClinicalTrials.gov registry record · Phase 4
A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 300
- Enrollment target
NCT00644631 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 300 participants.
The verdict
NCT00644631, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 300 participants
- Enrollment target
Study Summary
To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.
Interventions
- DRUG placebo
- DRUG sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2003-06 |
| Est. Completion | 2004-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00644631
The ClinicalTrials.gov registry entry for NCT00644631 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00644631 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00644631 about?
NCT00644631 is a clinical study titled "A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate". To compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" ...
What is the current status of trial NCT00644631?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. The study started on 2003-06. Estimated completion is 2004-04.
What interventions are being tested in trial NCT00644631?
The interventions under investigation include: placebo (DRUG), sildenafil (DRUG).
Who is sponsoring clinical trial NCT00644631?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
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