Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

May 20, 2014 updated by: Sprout Pharmaceuticals, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
        • 511.118.43005 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 511.118.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 511.118.43004 Boehringer Ingelheim Investigational Site
      • Wörgl, Austria
        • 511.118.43006 Boehringer Ingelheim Investigational Site
  • Belgium
      • Braine-l'Alleud, Belgium
        • 511.118.32004 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 511.118.32003 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 511.118.32005 Boehringer Ingelheim Investigational Site
      • Hasselt, Belgium
        • 511.118.32006 Boehringer Ingelheim Investigational Site
      • Yvoir, Belgium
        • 511.118.32002 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic
        • 511.118.42001 Boehringer Ingelheim Investigational Site
      • Prague, Czech Republic
        • 511.118.42002 Boehringer Ingelheim Investigational Site
      • Prague, Czech Republic
        • 511.118.42003 Boehringer Ingelheim Investigational Site
      • Vresina, Czech Republic
        • 511.118.42004 Boehringer Ingelheim Investigational Site
  • Finland
      • Espoo, Finland
        • 511.118.35801 Boehringer Ingelheim Investigational Site
      • Helsinki, Finland
        • 511.118.35805 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 511.118.35802 Boehringer Ingelheim Investigational Site
      • Seinäjoki, Finland
        • 511.118.35803 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 511.118.35804 Boehringer Ingelheim Investigational Site
  • France
      • Blanquefort, France
        • 511.118.3308A Boehringer Ingelheim Investigational Site
      • Bordeaux Cedex, France
        • 511.118.3301A Boehringer Ingelheim Investigational Site
      • La Rochelle, France
        • 511.118.3305A Boehringer Ingelheim Investigational Site
      • Lille, France
        • 511.118.3314A Boehringer Ingelheim Investigational Site
      • Lille, France
        • 511.118.3314B Cabinet médical
      • Marseille, France
        • 511.118.3310A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 511.118.3312A Boehringer Ingelheim Investigational Site
      • Marseille Cedex 9, France
        • 511.118.3303A Boehringer Ingelheim Investigational Site
      • Rennes, France
        • 511.118.3315A Cabinet Médical
      • Saint Emilion, France
        • 511.118.3306A Boehringer Ingelheim Investigational Site
      • Toulouse, France
        • 511.118.3311A Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 511.118.49004 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 511.118.49001 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 511.118.49006 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 511.118.49008 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 511.118.49003 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 511.118.49002 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 511.118.49005 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 511.118.36001 Boehringer Ingelheim Investigational Site
      • Kecskemét, Hungary
        • 511.118.36005 Boehringer Ingelheim Investigational Site
      • Szeged, Hungary
        • 511.118.36003 Boehringer Ingelheim Investigational Site
      • Szentes, Hungary
        • 511.118.36004 Boehringer Ingelheim Investigational Site
  • Italy
      • Catania, Italy
        • 511.118.39004 Boehringer Ingelheim Investigational Site
      • Pavia, Italy
        • 511.118.39001 Boehringer Ingelheim Investigational Site
      • Torino, Italy
        • 511.118.39003 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Almere, Netherlands
        • 511.118.31006 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 511.118.31001 Boehringer Ingelheim Investigational Site
      • Apeldoorn, Netherlands
        • 511.118.31004 Boehringer Ingelheim Investigational Site
      • Bilthoven, Netherlands
        • 511.118.31003 Boehringer Ingelheim Investigational Site
      • Den Helder, Netherlands
        • 511.118.31007 Boehringer Ingelheim Investigational Site
      • Enschede, Netherlands
        • 511.118.31005 Boehringer Ingelheim Investigational Site
      • Nieuwegein, Netherlands
        • 511.118.31002 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 511.118.34004 Boehringer Ingelheim Investigational Site
      • Manresa (Barcelona), Spain
        • 511.118.34003 Boehringer Ingelheim Investigational Site
      • Mataró-Barcelona, Spain
        • 511.118.34002 Boehringer Ingelheim Investigational Site
      • Orense, Spain
        • 511.118.34001 Boehringer Ingelheim Investigational Site
  • Sweden
      • Kungsbacka, Sweden
        • 511.118.46004 Boehringer Ingelheim Investigational Site
      • Lund, Sweden
        • 511.118.46009 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 511.118.46001 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 511.118.46006 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 511.118.46005 Boehringer Ingelheim Investigational Site
      • Vasteras, Sweden
        • 511.118.46003 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Chorley, United Kingdom
        • 511.118.44009 Boehringer Ingelheim Investigational Site
      • Fisherwick, Lichfield, United Kingdom
        • 511.118.44004 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 511.118.44008 Boehringer Ingelheim Investigational Site
      • Headington, Oxford, United Kingdom
        • 511.118.44003 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 511.118.44001 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 511.118.44002 Boehringer Ingelheim Investigational Site
      • South Brent, United Kingdom
        • 511.118.44007 Boehringer Ingelheim Investigational Site
      • Waterloo, Liverpool, United Kingdom
        • 511.118.44010 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with a primary diagnosis of HSDD who still needs to be treated according to the investigator's opinion and willing to continue in this study. This continuation requires adequate compliance, in the Investigators judgement, with trial medication and the trial visit required in the parent clinical trial (Visit 1 to visit 9).
  • Patients must have used a medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive), intrauterine device, tubal sterilization, or partner's surgical sterilization] for at least 3 months before the Screen Visit and continue to use that medically acceptable method of contraception during the trial.

Exclusion Criteria:

  • Patients with a history of MDD within 6 months prior the Screen Visit or a score of 14 on the Beck Depression Inventory II, or a history of suicide attempt according to the Beck Scale for Suicide Ideation, or patient with any non-zero statement in the first five items for the Beck Scale for Suicide Ideation.
  • Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Inclusion Visit.
  • Patients with findings at the Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
  • Patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
  • Clinically significant ECG abnormalities at the Screen Visit, according to the investigators opinion or the cardiologist who have performed the ECG. The following ECG values are considered to be exclusionary: QTc intervals >480 milliseconds (ms), PR intervals >240 ms, and QRS intervals >110 ms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: flibanserin flexible dose

Initial dosage:

Patients were to take one 50 mg flibanserin tablet in the evening.

Subsequent dosage titrations:

Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.

Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.

Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.
Drug: flibanserin flexible dose

Initial dosage:

Patients were to take one 50 mg flibanserin tablet in the evening.

Subsequent dosage titrations:

Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.

Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY.

Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sprout Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

June 20, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexual Dysfunctions, Psychological

Clinical Trials on flibanserin flexible dose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe