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Flibanserin Versus Placebo in Premenopausal Women With HSDD

Primary Purpose

Sexual Dysfunctions, Psychological

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
50 mg qhs
100 mg
placebo
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:

  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.

Sites / Locations

  • 511.77.43005 Boehringer Ingelheim Investigational Site
  • 511.77.43001 Boehringer Ingelheim Investigational Site
  • 511.77.43002 Boehringer Ingelheim Investigational Site
  • 511.77.43004 Boehringer Ingelheim Investigational Site
  • 511.77.43006 Boehringer Ingelheim Investigational Site
  • 511.77.32004 Boehringer Ingelheim Investigational Site
  • 511.77.32003 Boehringer Ingelheim Investigational Site
  • 511.77.32005 Boehringer Ingelheim Investigational Site
  • 511.77.32006 Boehringer Ingelheim Investigational Site
  • 511.77.32002 Boehringer Ingelheim Investigational Site
  • 511.77.42001 Boehringer Ingelheim Investigational Site
  • 511.77.42002 Boehringer Ingelheim Investigational Site
  • 511.77.42003 Boehringer Ingelheim Investigational Site
  • 511.77.42004 Boehringer Ingelheim Investigational Site
  • 511.77.35801 Boehringer Ingelheim Investigational Site
  • 511.77.35805 Boehringer Ingelheim Investigational Site
  • 511.77.35802 Boehringer Ingelheim Investigational Site
  • 511.77.35803 Boehringer Ingelheim Investigational Site
  • 511.77.35804 Boehringer Ingelheim Investigational Site
  • 511.77.3308A Boehringer Ingelheim Investigational Site
  • 511.77.3301A Boehringer Ingelheim Investigational Site
  • 511.77.3305A Boehringer Ingelheim Investigational Site
  • 511.77.3314A Boehringer Ingelheim Investigational Site
  • 511.77.3314B Cabinet médical
  • 511.77.3314C Cabinet médical
  • 511.77.3303A Boehringer Ingelheim Investigational Site
  • 511.77.3310A Boehringer Ingelheim Investigational Site
  • 511.77.3312A Boehringer Ingelheim Investigational Site
  • 511.77.3302A Boehringer Ingelheim Investigational Site
  • 511.77.3315A Cabinet Médical
  • 511.77.3306A Boehringer Ingelheim Investigational Site
  • 511.77.3311A Boehringer Ingelheim Investigational Site
  • 511.77.49004 Boehringer Ingelheim Investigational Site
  • 511.77.49007 Boehringer Ingelheim Investigational Site
  • 511.77.49001 Boehringer Ingelheim Investigational Site
  • 511.77.49006 Boehringer Ingelheim Investigational Site
  • 511.77.49008 Boehringer Ingelheim Investigational Site
  • 511.77.49003 Boehringer Ingelheim Investigational Site
  • 511.77.49002 Boehringer Ingelheim Investigational Site
  • 511.77.49005 Boehringer Ingelheim Investigational Site
  • 511.77.49009 Boehringer Ingelheim Investigational Site
  • 511.77.36001 Boehringer Ingelheim Investigational Site
  • 511.77.36005 Boehringer Ingelheim Investigational Site
  • 511.77.36003 Boehringer Ingelheim Investigational Site
  • 511.77.36004 Boehringer Ingelheim Investigational Site
  • 511.77.39004 Ospedale S. Bambino
  • 511.77.39001 IRCCS S. Fondazione Maugeri
  • 511.77.39002 Ospedale Santa Chiara
  • 511.77.39003 Ospedale Sant'Anna
  • 511.77.31006 Boehringer Ingelheim Investigational Site
  • 511.77.31001 Boehringer Ingelheim Investigational Site
  • 511.77.31004 Boehringer Ingelheim Investigational Site
  • 511.77.31009 Boehringer Ingelheim Investigational Site
  • 511.77.31007 Boehringer Ingelheim Investigational Site
  • 511.77.31005 Boehringer Ingelheim Investigational Site
  • 511.77.31002 St Antonius ziekenhuis
  • 511.77.31008 Boehringer Ingelheim Investigational Site
  • 511.77.31003 Boehringer Ingelheim Investigational Site
  • 511.77.47002 Boehringer Ingelheim Investigational Site
  • 511.77.47001 Boehringer Ingelheim Investigational Site
  • 511.77.47003 Boehringer Ingelheim Investigational Site
  • 511.77.47004 Boehringer Ingelheim Investigational Site
  • 511.77.34004 Boehringer Ingelheim Investigational Site
  • 511.77.34005 Boehringer Ingelheim Investigational Site
  • 511.77.34006 Boehringer Ingelheim Investigational Site
  • 511.77.34003 Boehringer Ingelheim Investigational Site
  • 511.77.34002 Boehringer Ingelheim Investigational Site
  • 511.77.34001 Boehringer Ingelheim Investigational Site
  • 511.77.46004 Boehringer Ingelheim Investigational Site
  • 511.77.46009 Boehringer Ingelheim Investigational Site
  • 511.77.46007 Boehringer Ingelheim Investigational Site
  • 511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken
  • 511.77.46002 Boehringer Ingelheim Investigational Site
  • 511.77.46006 Boehringer Ingelheim Investigational Site
  • 511.77.46005 Boehringer Ingelheim Investigational Site
  • 511.77.46003 Boehringer Ingelheim Investigational Site
  • 511.77.44011 Boehringer Ingelheim Investigational Site
  • 511.77.44009 Boehringer Ingelheim Investigational Site
  • 511.77.44004 Boehringer Ingelheim Investigational Site
  • 511.77.44008 Boehringer Ingelheim Investigational Site
  • 511.77.44003 Boehringer Ingelheim Investigational Site
  • 511.77.44005 Boehringer Ingelheim Investigational Site
  • 511.77.44001 Boehringer Ingelheim Investigational Site
  • 511.77.44002 Boehringer Ingelheim Investigational Site
  • 511.77.44007 Boehringer Ingelheim Investigational Site
  • 511.77.44010 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

flibanserin

flibanserin 100mg

placebo

Arm Description

50 mg qhs

100 mg qhs

placebo qhs

Outcomes

Primary Outcome Measures

Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
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?"

Secondary Outcome Measures

Full Information

First Posted
June 25, 2007
Last Updated
May 6, 2014
Sponsor
Sprout Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00491829
Brief Title
Flibanserin Versus Placebo in Premenopausal Women With HSDD
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 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
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.

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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
945 (Actual)

8. Arms, Groups, and Interventions

Arm Title
flibanserin
Arm Type
Experimental
Arm Description
50 mg qhs
Arm Title
flibanserin 100mg
Arm Type
Experimental
Arm Description
100 mg qhs
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo qhs
Intervention Type
Drug
Intervention Name(s)
50 mg qhs
Intervention Description
flibanserin 50 mg
Intervention Type
Drug
Intervention Name(s)
100 mg
Intervention Description
flibanserin 100mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
Description
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?"
Time Frame
baseline to 24 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who are 18 years of age and older at the Screen Visit. 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 A score of 15 or higher on the Female Sexual Distress Scale-Revised (FSDS-R)© (R04-1068) at the Screen Visit. Item Number Two of the Sexual Interest and Desire Inventory - Female© (SIDI-F©) must be rated as "0" or "1" at the Screen Visit Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly. 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). 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. 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: 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. 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. 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 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. Patients who indicate that their sexual partner has organic or psychosexual dysfunction that could interfere with a patient response to treatment. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
511.77.43005 Boehringer Ingelheim Investigational Site
City
Innsbruck
Country
Austria
Facility Name
511.77.43001 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
511.77.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
511.77.43004 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
511.77.43006 Boehringer Ingelheim Investigational Site
City
Wörgl
Country
Austria
Facility Name
511.77.32004 Boehringer Ingelheim Investigational Site
City
Braine-l'Alleud
Country
Belgium
Facility Name
511.77.32003 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
511.77.32005 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
511.77.32006 Boehringer Ingelheim Investigational Site
City
Hasselt
Country
Belgium
Facility Name
511.77.32002 Boehringer Ingelheim Investigational Site
City
Yvoir
Country
Belgium
Facility Name
511.77.42001 Boehringer Ingelheim Investigational Site
City
Olomouc
Country
Czech Republic
Facility Name
511.77.42002 Boehringer Ingelheim Investigational Site
City
Prague
Country
Czech Republic
Facility Name
511.77.42003 Boehringer Ingelheim Investigational Site
City
Prague
Country
Czech Republic
Facility Name
511.77.42004 Boehringer Ingelheim Investigational Site
City
Vresina
Country
Czech Republic
Facility Name
511.77.35801 Boehringer Ingelheim Investigational Site
City
Espoo
Country
Finland
Facility Name
511.77.35805 Boehringer Ingelheim Investigational Site
City
Helsinki
Country
Finland
Facility Name
511.77.35802 Boehringer Ingelheim Investigational Site
City
Oulu
Country
Finland
Facility Name
511.77.35803 Boehringer Ingelheim Investigational Site
City
Seinäjoki
Country
Finland
Facility Name
511.77.35804 Boehringer Ingelheim Investigational Site
City
Tampere
Country
Finland
Facility Name
511.77.3308A Boehringer Ingelheim Investigational Site
City
Blanquefort
Country
France
Facility Name
511.77.3301A Boehringer Ingelheim Investigational Site
City
Bordeaux
Country
France
Facility Name
511.77.3305A Boehringer Ingelheim Investigational Site
City
La Rochelle
Country
France
Facility Name
511.77.3314A Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
511.77.3314B Cabinet médical
City
Lille
Country
France
Facility Name
511.77.3314C Cabinet médical
City
Lille
Country
France
Facility Name
511.77.3303A Boehringer Ingelheim Investigational Site
City
Marseille Cedex 9
Country
France
Facility Name
511.77.3310A Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
511.77.3312A Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
511.77.3302A Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
511.77.3315A Cabinet Médical
City
Rennes
Country
France
Facility Name
511.77.3306A Boehringer Ingelheim Investigational Site
City
Saint Emilion
Country
France
Facility Name
511.77.3311A Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
511.77.49004 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
511.77.49007 Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
511.77.49001 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
511.77.49006 Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
511.77.49008 Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
511.77.49003 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
511.77.49002 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
511.77.49005 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
511.77.49009 Boehringer Ingelheim Investigational Site
City
Magdeburg
Country
Germany
Facility Name
511.77.36001 Boehringer Ingelheim Investigational Site
City
Budapest
Country
Hungary
Facility Name
511.77.36005 Boehringer Ingelheim Investigational Site
City
Kecskemét
Country
Hungary
Facility Name
511.77.36003 Boehringer Ingelheim Investigational Site
City
Szeged
Country
Hungary
Facility Name
511.77.36004 Boehringer Ingelheim Investigational Site
City
Szentes
Country
Hungary
Facility Name
511.77.39004 Ospedale S. Bambino
City
Catania
Country
Italy
Facility Name
511.77.39001 IRCCS S. Fondazione Maugeri
City
Pavia
Country
Italy
Facility Name
511.77.39002 Ospedale Santa Chiara
City
Pisa
Country
Italy
Facility Name
511.77.39003 Ospedale Sant'Anna
City
Torino
Country
Italy
Facility Name
511.77.31006 Boehringer Ingelheim Investigational Site
City
Almere
Country
Netherlands
Facility Name
511.77.31001 Boehringer Ingelheim Investigational Site
City
Amsterdam
Country
Netherlands
Facility Name
511.77.31004 Boehringer Ingelheim Investigational Site
City
Apeldoorn
Country
Netherlands
Facility Name
511.77.31009 Boehringer Ingelheim Investigational Site
City
Den Haag
Country
Netherlands
Facility Name
511.77.31007 Boehringer Ingelheim Investigational Site
City
Den Helder
Country
Netherlands
Facility Name
511.77.31005 Boehringer Ingelheim Investigational Site
City
Enschede
Country
Netherlands
Facility Name
511.77.31002 St Antonius ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
511.77.31008 Boehringer Ingelheim Investigational Site
City
Tilburg
Country
Netherlands
Facility Name
511.77.31003 Boehringer Ingelheim Investigational Site
City
Zeist
Country
Netherlands
Facility Name
511.77.47002 Boehringer Ingelheim Investigational Site
City
Lillestrøm
Country
Norway
Facility Name
511.77.47001 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
511.77.47003 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
511.77.47004 Boehringer Ingelheim Investigational Site
City
Oslo
Country
Norway
Facility Name
511.77.34004 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
511.77.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
511.77.34006 Boehringer Ingelheim Investigational Site
City
L´Hospitalet del LLobregat
Country
Spain
Facility Name
511.77.34003 Boehringer Ingelheim Investigational Site
City
Manresa (Barcelona)
Country
Spain
Facility Name
511.77.34002 Boehringer Ingelheim Investigational Site
City
Mataró-Barcelona
Country
Spain
Facility Name
511.77.34001 Boehringer Ingelheim Investigational Site
City
Orense
Country
Spain
Facility Name
511.77.46004 Boehringer Ingelheim Investigational Site
City
Kungsbacka
Country
Sweden
Facility Name
511.77.46009 Boehringer Ingelheim Investigational Site
City
Lund
Country
Sweden
Facility Name
511.77.46007 Boehringer Ingelheim Investigational Site
City
Malmö
Country
Sweden
Facility Name
511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken
City
Stockholm
Country
Sweden
Facility Name
511.77.46002 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
511.77.46006 Boehringer Ingelheim Investigational Site
City
Stockholm
Country
Sweden
Facility Name
511.77.46005 Boehringer Ingelheim Investigational Site
City
Uppsala
Country
Sweden
Facility Name
511.77.46003 Boehringer Ingelheim Investigational Site
City
Västerås
Country
Sweden
Facility Name
511.77.44011 Boehringer Ingelheim Investigational Site
City
Belfast
Country
United Kingdom
Facility Name
511.77.44009 Boehringer Ingelheim Investigational Site
City
Chorley
Country
United Kingdom
Facility Name
511.77.44004 Boehringer Ingelheim Investigational Site
City
Fisherwick, Lichfield
Country
United Kingdom
Facility Name
511.77.44008 Boehringer Ingelheim Investigational Site
City
Glasgow
Country
United Kingdom
Facility Name
511.77.44003 Boehringer Ingelheim Investigational Site
City
Headington, Oxford
Country
United Kingdom
Facility Name
511.77.44005 Boehringer Ingelheim Investigational Site
City
Leeds
Country
United Kingdom
Facility Name
511.77.44001 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
511.77.44002 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
511.77.44007 Boehringer Ingelheim Investigational Site
City
South Brent
Country
United Kingdom
Facility Name
511.77.44010 Boehringer Ingelheim Investigational Site
City
Waterloo, Liverpool
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Flibanserin Versus Placebo in Premenopausal Women With HSDD

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