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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: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.

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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 300 participants
Start Date 2003-06
Est. Completion 2004-04
Phase Phase 4

What the finished NCT00644631 record still lists

NCT00644631 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 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.

NCT00644631 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00644631's enrollment target sits among peer trials

300 269th of 2000 higher than 1,709 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00644631, the US trial registry maintained by the National Library of Medicine. NCT00644631 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.