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Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
flibanserin flexible dose
Sponsored by
Sprout Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Dysfunctions, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • 511.118.43005 Boehringer Ingelheim Investigational Site
  • 511.118.43002 Boehringer Ingelheim Investigational Site
  • 511.118.43004 Boehringer Ingelheim Investigational Site
  • 511.118.43006 Boehringer Ingelheim Investigational Site
  • 511.118.32004 Boehringer Ingelheim Investigational Site
  • 511.118.32003 Boehringer Ingelheim Investigational Site
  • 511.118.32005 Boehringer Ingelheim Investigational Site
  • 511.118.32006 Boehringer Ingelheim Investigational Site
  • 511.118.32002 Boehringer Ingelheim Investigational Site
  • 511.118.42001 Boehringer Ingelheim Investigational Site
  • 511.118.42002 Boehringer Ingelheim Investigational Site
  • 511.118.42003 Boehringer Ingelheim Investigational Site
  • 511.118.42004 Boehringer Ingelheim Investigational Site
  • 511.118.35801 Boehringer Ingelheim Investigational Site
  • 511.118.35805 Boehringer Ingelheim Investigational Site
  • 511.118.35802 Boehringer Ingelheim Investigational Site
  • 511.118.35803 Boehringer Ingelheim Investigational Site
  • 511.118.35804 Boehringer Ingelheim Investigational Site
  • 511.118.3308A Boehringer Ingelheim Investigational Site
  • 511.118.3301A Boehringer Ingelheim Investigational Site
  • 511.118.3305A Boehringer Ingelheim Investigational Site
  • 511.118.3314A Boehringer Ingelheim Investigational Site
  • 511.118.3314B Cabinet médical
  • 511.118.3303A Boehringer Ingelheim Investigational Site
  • 511.118.3310A Boehringer Ingelheim Investigational Site
  • 511.118.3312A Boehringer Ingelheim Investigational Site
  • 511.118.3315A Cabinet Médical
  • 511.118.3306A Boehringer Ingelheim Investigational Site
  • 511.118.3311A Boehringer Ingelheim Investigational Site
  • 511.118.49004 Boehringer Ingelheim Investigational Site
  • 511.118.49001 Boehringer Ingelheim Investigational Site
  • 511.118.49006 Boehringer Ingelheim Investigational Site
  • 511.118.49008 Boehringer Ingelheim Investigational Site
  • 511.118.49003 Boehringer Ingelheim Investigational Site
  • 511.118.49002 Boehringer Ingelheim Investigational Site
  • 511.118.49005 Boehringer Ingelheim Investigational Site
  • 511.118.36001 Boehringer Ingelheim Investigational Site
  • 511.118.36005 Boehringer Ingelheim Investigational Site
  • 511.118.36003 Boehringer Ingelheim Investigational Site
  • 511.118.36004 Boehringer Ingelheim Investigational Site
  • 511.118.39004 Boehringer Ingelheim Investigational Site
  • 511.118.39001 Boehringer Ingelheim Investigational Site
  • 511.118.39003 Boehringer Ingelheim Investigational Site
  • 511.118.31006 Boehringer Ingelheim Investigational Site
  • 511.118.31001 Boehringer Ingelheim Investigational Site
  • 511.118.31004 Boehringer Ingelheim Investigational Site
  • 511.118.31003 Boehringer Ingelheim Investigational Site
  • 511.118.31007 Boehringer Ingelheim Investigational Site
  • 511.118.31005 Boehringer Ingelheim Investigational Site
  • 511.118.31002 Boehringer Ingelheim Investigational Site
  • 511.118.34004 Boehringer Ingelheim Investigational Site
  • 511.118.34003 Boehringer Ingelheim Investigational Site
  • 511.118.34002 Boehringer Ingelheim Investigational Site
  • 511.118.34001 Boehringer Ingelheim Investigational Site
  • 511.118.46004 Boehringer Ingelheim Investigational Site
  • 511.118.46009 Boehringer Ingelheim Investigational Site
  • 511.118.46001 Boehringer Ingelheim Investigational Site
  • 511.118.46006 Boehringer Ingelheim Investigational Site
  • 511.118.46005 Boehringer Ingelheim Investigational Site
  • 511.118.46003 Boehringer Ingelheim Investigational Site
  • 511.118.44009 Boehringer Ingelheim Investigational Site
  • 511.118.44004 Boehringer Ingelheim Investigational Site
  • 511.118.44008 Boehringer Ingelheim Investigational Site
  • 511.118.44003 Boehringer Ingelheim Investigational Site
  • 511.118.44001 Boehringer Ingelheim Investigational Site
  • 511.118.44002 Boehringer Ingelheim Investigational Site
  • 511.118.44007 Boehringer Ingelheim Investigational Site
  • 511.118.44010 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

flibanserin flexible dose

Arm Description

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.

Outcomes

Primary Outcome Measures

Frequency of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
January 15, 2008
Last Updated
May 20, 2014
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00601367
Brief Title
Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder
Official Title
A Twenty-Eight Week, Open-Label, Safety Study of Flibanserin 50 Mgs to 100 Mgs Daily in Premenopausal European Women With HSDD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sprout Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunctions, Psychological

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin flexible dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
flibanserin flexible dose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of Adverse Events
Time Frame
28 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sprout Pharmaceuticals
Organizational Affiliation
Sprout Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
511.118.43005 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
511.118.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
511.118.43004 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
511.118.43006 Boehringer Ingelheim Investigational Site
City
Wörgl
Country
Austria
Facility Name
511.118.32004 Boehringer Ingelheim Investigational Site
City
Braine-l'Alleud
Country
Belgium
Facility Name
511.118.32003 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
511.118.32005 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
511.118.32006 Boehringer Ingelheim Investigational Site
City
Hasselt
Country
Belgium
Facility Name
511.118.32002 Boehringer Ingelheim Investigational Site
City
Yvoir
Country
Belgium
Facility Name
511.118.42001 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
511.118.42002 Boehringer Ingelheim Investigational Site
City
Prague
Country
Czech Republic
Facility Name
511.118.42003 Boehringer Ingelheim Investigational Site
City
Prague
Country
Czech Republic
Facility Name
511.118.42004 Boehringer Ingelheim Investigational Site
City
Vresina
Country
Czech Republic
Facility Name
511.118.35801 Boehringer Ingelheim Investigational Site
City
Espoo
Country
Finland
Facility Name
511.118.35805 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
511.118.35802 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
511.118.35803 Boehringer Ingelheim Investigational Site
City
Seinäjoki
Country
Finland
Facility Name
511.118.35804 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
511.118.3308A Boehringer Ingelheim Investigational Site
City
Blanquefort
Country
France
Facility Name
511.118.3301A Boehringer Ingelheim Investigational Site
City
Bordeaux Cedex
Country
France
Facility Name
511.118.3305A Boehringer Ingelheim Investigational Site
City
La Rochelle
Country
France
Facility Name
511.118.3314A Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
511.118.3314B Cabinet médical
City
Lille
Country
France
Facility Name
511.118.3303A Boehringer Ingelheim Investigational Site
City
Marseille Cedex 9
Country
France
Facility Name
511.118.3310A Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
511.118.3312A Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
511.118.3315A Cabinet Médical
City
Rennes
Country
France
Facility Name
511.118.3306A Boehringer Ingelheim Investigational Site
City
Saint Emilion
Country
France
Facility Name
511.118.3311A Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
511.118.49004 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
511.118.49001 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
511.118.49006 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
511.118.49008 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
511.118.49003 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
511.118.49002 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
511.118.49005 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
511.118.36001 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
511.118.36005 Boehringer Ingelheim Investigational Site
City
Kecskemét
Country
Hungary
Facility Name
511.118.36003 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
511.118.36004 Boehringer Ingelheim Investigational Site
City
Szentes
Country
Hungary
Facility Name
511.118.39004 Boehringer Ingelheim Investigational Site
City
Catania
Country
Italy
Facility Name
511.118.39001 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
511.118.39003 Boehringer Ingelheim Investigational Site
City
Torino
Country
Italy
Facility Name
511.118.31006 Boehringer Ingelheim Investigational Site
City
Almere
Country
Netherlands
Facility Name
511.118.31001 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
511.118.31004 Boehringer Ingelheim Investigational Site
City
Apeldoorn
Country
Netherlands
Facility Name
511.118.31003 Boehringer Ingelheim Investigational Site
City
Bilthoven
Country
Netherlands
Facility Name
511.118.31007 Boehringer Ingelheim Investigational Site
City
Den Helder
Country
Netherlands
Facility Name
511.118.31005 Boehringer Ingelheim Investigational Site
City
Enschede
Country
Netherlands
Facility Name
511.118.31002 Boehringer Ingelheim Investigational Site
City
Nieuwegein
Country
Netherlands
Facility Name
511.118.34004 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
511.118.34003 Boehringer Ingelheim Investigational Site
City
Manresa (Barcelona)
Country
Spain
Facility Name
511.118.34002 Boehringer Ingelheim Investigational Site
City
Mataró-Barcelona
Country
Spain
Facility Name
511.118.34001 Boehringer Ingelheim Investigational Site
City
Orense
Country
Spain
Facility Name
511.118.46004 Boehringer Ingelheim Investigational Site
City
Kungsbacka
Country
Sweden
Facility Name
511.118.46009 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
Facility Name
511.118.46001 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
511.118.46006 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
511.118.46005 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
511.118.46003 Boehringer Ingelheim Investigational Site
City
Vasteras
Country
Sweden
Facility Name
511.118.44009 Boehringer Ingelheim Investigational Site
City
Chorley
Country
United Kingdom
Facility Name
511.118.44004 Boehringer Ingelheim Investigational Site
City
Fisherwick, Lichfield
Country
United Kingdom
Facility Name
511.118.44008 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
511.118.44003 Boehringer Ingelheim Investigational Site
City
Headington, Oxford
Country
United Kingdom
Facility Name
511.118.44001 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
511.118.44002 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
511.118.44007 Boehringer Ingelheim Investigational Site
City
South Brent
Country
United Kingdom
Facility Name
511.118.44010 Boehringer Ingelheim Investigational Site
City
Waterloo, Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder

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