Who is sponsoring NCT00601367?

NCT00601367 is sponsored by Sprout Pharmaceuticals, Inc.

What drugs are being tested in NCT00601367?

Interventions in NCT00601367: flibanserin flexible dose.

What condition does NCT00601367 study?

NCT00601367 studies Sexual Dysfunctions, Psychological.

Is NCT00601367 still recruiting?

NCT00601367 is currently completed. Last updated 20 May 2014.

Are results published for NCT00601367?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-05-20 · How we verify

NCT00601367

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD

Completed Phase 3 Results posted Last updated 20 May 2014

What this trial tests

Phase 3 trial testing flibanserin flexible dose in Sexual Dysfunctions, Psychological in 480 participants. Completed in 1 October 2009.

Timeline

1 January 2008

Primary endpoint
1 October 2009

1 October 2009

Quick facts

Lead sponsor	Sprout Pharmaceuticals, Inc
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	480
Start date	1 January 2008
Primary completion	1 October 2009
Estimated completion	1 October 2009
Sites	68 locations across Austria, Belgium, Czechia, Finland, France, Germany, Hungary, Italy

Drugs / interventions tested

flibanserin flexible dose — full drug profile →

Conditions studied

Sexual Dysfunctions, Psychological — all drugs for Sexual Dysfunctions, Psychological →

Sponsor

Sprout Pharmaceuticals, Inc — full company profile →

Who can join

18 and older, female only, with Sexual Dysfunctions, Psychological. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Frequency of Adverse Events
Time frame: 28 weeks

Sponsor's own description

Safety profile of flibanserin over 28 additional weeks Distribution of preferred dose regimens

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Sexual Dysfunctions, Psychological

Currently open trials in the same condition.

NCT07048145 — Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women · NA · active not recruiting
NCT05777031 — Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease · Phase 4 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00601367 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sprout Pharmaceuticals, Inc
Last refreshed: 20 May 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00601367.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing