Flibanserin Versus Placebo in Premenopausal Women With HSDD

May 6, 2014 updated by: Sprout Pharmaceuticals, Inc

A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

945

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
        • 511.77.43005 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 511.77.43001 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 511.77.43002 Boehringer Ingelheim Investigational Site
      • Wien, Austria
        • 511.77.43004 Boehringer Ingelheim Investigational Site
      • Wörgl, Austria
        • 511.77.43006 Boehringer Ingelheim Investigational Site
  • Belgium
      • Braine-l'Alleud, Belgium
        • 511.77.32004 Boehringer Ingelheim Investigational Site
      • Edegem, Belgium
        • 511.77.32003 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 511.77.32005 Boehringer Ingelheim Investigational Site
      • Hasselt, Belgium
        • 511.77.32006 Boehringer Ingelheim Investigational Site
      • Yvoir, Belgium
        • 511.77.32002 Boehringer Ingelheim Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic
        • 511.77.42001 Boehringer Ingelheim Investigational Site
      • Prague, Czech Republic
        • 511.77.42002 Boehringer Ingelheim Investigational Site
      • Prague, Czech Republic
        • 511.77.42003 Boehringer Ingelheim Investigational Site
      • Vresina, Czech Republic
        • 511.77.42004 Boehringer Ingelheim Investigational Site
  • Finland
      • Espoo, Finland
        • 511.77.35801 Boehringer Ingelheim Investigational Site
      • Helsinki, Finland
        • 511.77.35805 Boehringer Ingelheim Investigational Site
      • Oulu, Finland
        • 511.77.35802 Boehringer Ingelheim Investigational Site
      • Seinäjoki, Finland
        • 511.77.35803 Boehringer Ingelheim Investigational Site
      • Tampere, Finland
        • 511.77.35804 Boehringer Ingelheim Investigational Site
  • France
      • Blanquefort, France
        • 511.77.3308A Boehringer Ingelheim Investigational Site
      • Bordeaux, France
        • 511.77.3301A Boehringer Ingelheim Investigational Site
      • La Rochelle, France
        • 511.77.3305A Boehringer Ingelheim Investigational Site
      • Lille, France
        • 511.77.3314A Boehringer Ingelheim Investigational Site
      • Lille, France
        • 511.77.3314B Cabinet médical
      • Lille, France
        • 511.77.3314C Cabinet médical
      • Marseille, France
        • 511.77.3310A Boehringer Ingelheim Investigational Site
      • Marseille, France
        • 511.77.3312A Boehringer Ingelheim Investigational Site
      • Marseille Cedex 9, France
        • 511.77.3303A Boehringer Ingelheim Investigational Site
      • Paris, France
        • 511.77.3302A Boehringer Ingelheim Investigational Site
      • Rennes, France
        • 511.77.3315A Cabinet Médical
      • Saint Emilion, France
        • 511.77.3306A Boehringer Ingelheim Investigational Site
      • Toulouse, France
        • 511.77.3311A Boehringer Ingelheim Investigational Site
  • Germany
      • Berlin, Germany
        • 511.77.49004 Boehringer Ingelheim Investigational Site
      • Bochum, Germany
        • 511.77.49007 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 511.77.49001 Boehringer Ingelheim Investigational Site
      • Dresden, Germany
        • 511.77.49006 Boehringer Ingelheim Investigational Site
      • Frankfurt, Germany
        • 511.77.49008 Boehringer Ingelheim Investigational Site
      • Freiburg, Germany
        • 511.77.49003 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 511.77.49002 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 511.77.49005 Boehringer Ingelheim Investigational Site
      • Magdeburg, Germany
        • 511.77.49009 Boehringer Ingelheim Investigational Site
  • Hungary
      • Budapest, Hungary
        • 511.77.36001 Boehringer Ingelheim Investigational Site
      • Kecskemét, Hungary
        • 511.77.36005 Boehringer Ingelheim Investigational Site
      • Szeged, Hungary
        • 511.77.36003 Boehringer Ingelheim Investigational Site
      • Szentes, Hungary
        • 511.77.36004 Boehringer Ingelheim Investigational Site
  • Italy
      • Catania, Italy
        • 511.77.39004 Ospedale S. Bambino
      • Pavia, Italy
        • 511.77.39001 IRCCS S. Fondazione Maugeri
      • Pisa, Italy
        • 511.77.39002 Ospedale Santa Chiara
      • Torino, Italy
        • 511.77.39003 Ospedale Sant'Anna
  • Netherlands
      • Almere, Netherlands
        • 511.77.31006 Boehringer Ingelheim Investigational Site
      • Amsterdam, Netherlands
        • 511.77.31001 Boehringer Ingelheim Investigational Site
      • Apeldoorn, Netherlands
        • 511.77.31004 Boehringer Ingelheim Investigational Site
      • Den Haag, Netherlands
        • 511.77.31009 Boehringer Ingelheim Investigational Site
      • Den Helder, Netherlands
        • 511.77.31007 Boehringer Ingelheim Investigational Site
      • Enschede, Netherlands
        • 511.77.31005 Boehringer Ingelheim Investigational Site
      • Nieuwegein, Netherlands
        • 511.77.31002 St Antonius ziekenhuis
      • Tilburg, Netherlands
        • 511.77.31008 Boehringer Ingelheim Investigational Site
      • Zeist, Netherlands
        • 511.77.31003 Boehringer Ingelheim Investigational Site
  • Norway
      • Lillestrøm, Norway
        • 511.77.47002 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 511.77.47001 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 511.77.47003 Boehringer Ingelheim Investigational Site
      • Oslo, Norway
        • 511.77.47004 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 511.77.34004 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 511.77.34005 Boehringer Ingelheim Investigational Site
      • L´Hospitalet del LLobregat, Spain
        • 511.77.34006 Boehringer Ingelheim Investigational Site
      • Manresa (Barcelona), Spain
        • 511.77.34003 Boehringer Ingelheim Investigational Site
      • Mataró-Barcelona, Spain
        • 511.77.34002 Boehringer Ingelheim Investigational Site
      • Orense, Spain
        • 511.77.34001 Boehringer Ingelheim Investigational Site
  • Sweden
      • Kungsbacka, Sweden
        • 511.77.46004 Boehringer Ingelheim Investigational Site
      • Lund, Sweden
        • 511.77.46009 Boehringer Ingelheim Investigational Site
      • Malmö, Sweden
        • 511.77.46007 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken
      • Stockholm, Sweden
        • 511.77.46002 Boehringer Ingelheim Investigational Site
      • Stockholm, Sweden
        • 511.77.46006 Boehringer Ingelheim Investigational Site
      • Uppsala, Sweden
        • 511.77.46005 Boehringer Ingelheim Investigational Site
      • Västerås, Sweden
        • 511.77.46003 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • Belfast, United Kingdom
        • 511.77.44011 Boehringer Ingelheim Investigational Site
      • Chorley, United Kingdom
        • 511.77.44009 Boehringer Ingelheim Investigational Site
      • Fisherwick, Lichfield, United Kingdom
        • 511.77.44004 Boehringer Ingelheim Investigational Site
      • Glasgow, United Kingdom
        • 511.77.44008 Boehringer Ingelheim Investigational Site
      • Headington, Oxford, United Kingdom
        • 511.77.44003 Boehringer Ingelheim Investigational Site
      • Leeds, United Kingdom
        • 511.77.44005 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 511.77.44001 Boehringer Ingelheim Investigational Site
      • London, United Kingdom
        • 511.77.44002 Boehringer Ingelheim Investigational Site
      • South Brent, United Kingdom
        • 511.77.44007 Boehringer Ingelheim Investigational Site
      • Waterloo, Liverpool, United Kingdom
        • 511.77.44010 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:

  1. Women who are 18 years of age and older at the Screen Visit.
  2. Premenopausal women per the Stages of Reproductive Aging Workshop (STRAW) criteria with the primary diagnosis of HSDD, generalized acquired type, according to DSM IV-TR criteria. The current episode must be at least 24 weeks in duration by the Baseline Visit. Secondary Female Sexual Arousal Disorder and/or Female Orgasmic Disorder are allowed. This inclusion criterion is met only if the HSDD commenced prior to Female Sexual Arousal Disorder and/or Female Orgasmic Disorder and the HSDD is of more importance to the patient, in the investigator judgement
  3. A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit.
  4. Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit
  5. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
  6. Patients must be willing and able to use an eDiary on a daily basis (e.g., have access to a working land line or wireless telephone for daily data transmissions).
  7. At the Baseline Visit, patients must have complied with eDiary use adequately, having missing entries for five or less days during the 28-day Screen period.
  8. Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The relationship is to be with the same partner who is sexually functional, both psychologically and physically, and the partner is expected to be physically present (i.e., available for sexual activity at some time during a 24 hour day) at least 50% of each month during the 4-week Screen period and 24-week efficacy period of the trial.

Exclusion Criteria:

  1. Patients who have taken any medication noted in Appendix 10.6.1, Part I - List of prohibited medications, within 30 days before the Screen Visit; the same medications are prohibited throughout participation in the study.
  2. Patients whose sexual function was affected (enhanced or worsened) in the investigator opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit. This must be determined by the investigator judgement after performing a detailed review of the patient sexual history and concomitant therapy.
  3. Patients with a history of drug dependence or abuse (including alcohol, as defined in DSM IV-TR or in the opinion of the investigator) within the past 1 year
  4. Patients who meet DSM IV-TR criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia (not caused by inadequate foreplay stimulation or alleviated by lubricants), Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition.
  5. Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment.
  6. Patients who have entered the peri-menopause stage (menopausal transition) or the post menopause stage [i.e., have had hysterectomy (without bilateral oophorectomy), bilateral oophorectomy, endometrial ablation (any type), and chemical induced (e.g., chemotherapy)] according to the STRAW criteria.
  7. 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.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: flibanserin
50 mg qhs
Drug: 50 mg qhs
flibanserin 50 mg
EXPERIMENTAL: flibanserin 100mg
100 mg qhs
Drug: 100 mg
flibanserin 100mg
PLACEBO_COMPARATOR: placebo
placebo qhs
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
Time Frame: baseline to 24 weeks
To obtain information on satisfying sexual events (SSEs), a small personal handheld electronic device was to be used by the patients to record such information daily (eDiary). An SSE was recorded when a patient answered "yes" to the eDiary question: "Was the event satisfying for you?"
baseline to 24 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

June 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (ESTIMATE)

June 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 2, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 511.77

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.

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