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NCT01103362 · ClinicalTrials.gov registry record · Phase 3

A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3 study, sponsored by Sprout Pharmaceuticals.

Terminated
Registry status
Phase 3
Development phase
596
Enrollment target

NCT01103362: Clinical Trial Phase 3 study, sponsored by Sprout Pharmaceuticals.

NCT01103362 is a Phase 3 study that was terminated before completion, run by Sprout Pharmaceuticals. The registered enrollment target is 596 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01103362, a Phase 3 study, was terminated before completion, sponsored by Sprout Pharmaceuticals.

TERMINATED
Registry status
Phase 3
Development phase
596 participants
Enrollment target

Study Summary

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Interventions

  • DRUG flibanserin

Trial Details

FieldValue
Enrollment Target 596 participants
Start Date 2010-04
Est. Completion 2011-01
Phase Phase 3
Sprout Pharmaceuticals

11 total trials

Why NCT01103362 stopped before completion

NCT01103362 is an interventional study that assigns participants to a tested intervention. The registered 596 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 1 intervention - of which flibanserin is the first listed.

NCT01103362 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01103362 about?

NCT01103362 is a clinical study titled "A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder". To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511....

What is the current status of trial NCT01103362?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 596 participants. The study started on 2010-04. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01103362?

The interventions under investigation include: flibanserin (DRUG).

Who is sponsoring clinical trial NCT01103362?

This trial is sponsored by Sprout Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01103362's enrollment target sits among peer trials

596 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01103362, the US trial registry maintained by the National Library of Medicine. NCT01103362 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.