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NCT01040208 · ClinicalTrials.gov registry record · Phase 3

12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress

A Phase 3 study, sponsored by Sprout Pharmaceuticals.

Terminated
Registry status
Phase 3
Development phase
111
Enrollment target

NCT01040208: Clinical Trial Phase 3 study, sponsored by Sprout Pharmaceuticals.

NCT01040208 is a Phase 3 study that was terminated before completion, run by Sprout Pharmaceuticals. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01040208, a Phase 3 study, was terminated before completion, sponsored by Sprout Pharmaceuticals.

TERMINATED
Registry status
Phase 3
Development phase
111 participants
Enrollment target

Study Summary

The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.

Interventions

  • DRUG flibanserin 50 mg to 100 mg qhs
  • DRUG flibanserin 100 mg qhs
  • DRUG placebo 2 tablets qhs

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2010-01
Est. Completion 2011-01
Phase Phase 3
Sprout Pharmaceuticals

11 total trials

Why NCT01040208 stopped before completion

NCT01040208 is an interventional study that assigns participants to a tested intervention. The registered 111 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 (86% lower).

The record links to 0 conditions, and to 3 interventions - of which flibanserin 50 mg to 100 mg qhs is the first listed.

NCT01040208 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01040208 about?

NCT01040208 is a clinical study titled "12 Week Safety Trial of Flibanserin in Depressed Women Taking an SSRI or SNRI With Decreased Sexual Desire and Distress". The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.

What is the current status of trial NCT01040208?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2010-01. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01040208?

The interventions under investigation include: flibanserin 50 mg to 100 mg qhs (DRUG), flibanserin 100 mg qhs (DRUG), placebo 2 tablets qhs (DRUG).

Who is sponsoring clinical trial NCT01040208?

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 NCT01040208's enrollment target sits among peer trials

111 1655th of 2000 higher than 344 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 NCT01040208, the US trial registry maintained by the National Library of Medicine. NCT01040208 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.