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NCT00360555 · ClinicalTrials.gov registry record · Phase 3

Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

A Phase 3 study of Sexual Dysfunctions, Psychological, sponsored by Sprout Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,584
Enrollment target
20
Study locations

NCT00360555 is a Phase 3 study of Sexual Dysfunctions, Psychological that has completed, run by Sprout Pharmaceuticals. The registered enrollment target is 1,584 participants. The trial reports 20 study locations across 7 states.

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The verdict

NCT00360555, a Phase 3 study of Sexual Dysfunctions, Psychological, has completed, sponsored by Sprout Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,584 participants
Enrollment target
20
Study locations

Study Summary

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Interventions

  • DRUG placebo
  • DRUG flibanserin
  • DRUG flibanserin 50mg
  • DRUG flibanserin 100mg

Study Locations (20)

California

  • 511.75.01017 Boehringer Ingelheim Investigational Site - Berkeley
  • 511.75.01014 Boehringer Ingelheim Investigational Site - Encinitas
  • 511.75.01042 Boehringer Ingelheim Investigational Site - Fair Oaks
  • 511.75.01022 Boehringer Ingelheim Investigational Site - Irvine
  • 511.75.01005 Boehringer Ingelheim Investigational Site - La Jolla
  • 511.75.01053 Boehringer Ingelheim Investigational Site - Sacremento
  • 511.75.01045 Boehringer Ingelheim Investigational Site - San Diego

Florida

  • 511.75.01066 Boehringer Ingelheim Investigational Site - Coral Gables
  • 511.75.01040 Boehringer Ingelheim Investigational Site - Fort Meyers
  • 511.75.01001 Boehringer Ingelheim Investigational Site - Gainesville
  • 511.75.01062 Boehringer Ingelheim Investigational Site - Hollywood
  • 511.75.01032 Boehringer Ingelheim Investigational Site - Ocala
  • 511.75.01047 Boehringer Ingelheim Investigational Site - Orlando

Alabama

  • 511.75.01015 Boehringer Ingelheim Investigational Site - Birmingham
  • 511.75.01028 Boehringer Ingelheim Investigational Site - Mobile

Colorado

  • 511.75.01065 Boehringer Ingelheim Investigational Site - Aurora
  • 511.75.01003 Boehringer Ingelheim Investigational Site - Englewood

Arizona

  • 511.75.01051 Boehringer Ingelheim Investigational Site - Phoenix

Arkansas

  • 511.75.01063 Boehringer Ingelheim Investigational Site - Little Rock

District of Columbia

  • 511.75.01030 Boehringer Ingelheim Investigational Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 1,584 participants
Start Date 2006-07
Est. Completion 2008-03
Phase Phase 3

Sponsor

Sprout Pharmaceuticals

11 total trials

What the Registry Record Tells You About NCT00360555

The ClinicalTrials.gov registry entry for NCT00360555 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,584 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sprout Pharmaceuticals, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sexual Dysfunctions, Psychological appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.

NCT00360555 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT00360555 about?

NCT00360555 is a clinical study titled "Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder". This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meets standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

What is the current status of trial NCT00360555?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,584 participants. The study started on 2006-07. Estimated completion is 2008-03.

What conditions does trial NCT00360555 study?

This clinical trial studies the following conditions: Sexual Dysfunctions, Psychological.

What interventions are being tested in trial NCT00360555?

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

Who is sponsoring clinical trial NCT00360555?

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

Where is trial NCT00360555 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.