Sexual Dysfunctions, Psychological Clinical Trial
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
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.
Status | Completed |
Enrollment | 945 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | 511.77.43005 Boehringer Ingelheim Investigational Site | Innsbruck | |
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 | Wien | |
Austria | 511.77.43006 Boehringer Ingelheim Investigational Site | Wörgl | |
Belgium | 511.77.32004 Boehringer Ingelheim Investigational Site | Braine-l'Alleud | |
Belgium | 511.77.32003 Boehringer Ingelheim Investigational Site | Edegem | |
Belgium | 511.77.32005 Boehringer Ingelheim Investigational Site | Gent | |
Belgium | 511.77.32006 Boehringer Ingelheim Investigational Site | Hasselt | |
Belgium | 511.77.32002 Boehringer Ingelheim Investigational Site | Yvoir | |
Czech Republic | 511.77.42001 Boehringer Ingelheim Investigational Site | Olomouc | |
Czech Republic | 511.77.42002 Boehringer Ingelheim Investigational Site | Prague | |
Czech Republic | 511.77.42003 Boehringer Ingelheim Investigational Site | Prague | |
Czech Republic | 511.77.42004 Boehringer Ingelheim Investigational Site | Vresina | |
Finland | 511.77.35801 Boehringer Ingelheim Investigational Site | Espoo | |
Finland | 511.77.35805 Boehringer Ingelheim Investigational Site | Helsinki | |
Finland | 511.77.35802 Boehringer Ingelheim Investigational Site | Oulu | |
Finland | 511.77.35803 Boehringer Ingelheim Investigational Site | Seinäjoki | |
Finland | 511.77.35804 Boehringer Ingelheim Investigational Site | Tampere | |
France | 511.77.3308A Boehringer Ingelheim Investigational Site | Blanquefort | |
France | 511.77.3301A Boehringer Ingelheim Investigational Site | Bordeaux | |
France | 511.77.3305A Boehringer Ingelheim Investigational Site | La Rochelle | |
France | 511.77.3314A Boehringer Ingelheim Investigational Site | Lille | |
France | 511.77.3314B Cabinet médical | Lille | |
France | 511.77.3314C Cabinet médical | Lille | |
France | 511.77.3310A Boehringer Ingelheim Investigational Site | Marseille | |
France | 511.77.3312A Boehringer Ingelheim Investigational Site | Marseille | |
France | 511.77.3303A Boehringer Ingelheim Investigational Site | Marseille Cedex 9 | |
France | 511.77.3302A Boehringer Ingelheim Investigational Site | Paris | |
France | 511.77.3315A Cabinet Médical | Rennes | |
France | 511.77.3306A Boehringer Ingelheim Investigational Site | Saint Emilion | |
France | 511.77.3311A Boehringer Ingelheim Investigational Site | Toulouse | |
Germany | 511.77.49004 Boehringer Ingelheim Investigational Site | Berlin | |
Germany | 511.77.49007 Boehringer Ingelheim Investigational Site | Bochum | |
Germany | 511.77.49001 Boehringer Ingelheim Investigational Site | Bonn | |
Germany | 511.77.49006 Boehringer Ingelheim Investigational Site | Dresden | |
Germany | 511.77.49008 Boehringer Ingelheim Investigational Site | Frankfurt | |
Germany | 511.77.49003 Boehringer Ingelheim Investigational Site | Freiburg | |
Germany | 511.77.49002 Boehringer Ingelheim Investigational Site | Hannover | |
Germany | 511.77.49005 Boehringer Ingelheim Investigational Site | Leipzig | |
Germany | 511.77.49009 Boehringer Ingelheim Investigational Site | Magdeburg | |
Hungary | 511.77.36001 Boehringer Ingelheim Investigational Site | Budapest | |
Hungary | 511.77.36005 Boehringer Ingelheim Investigational Site | Kecskemét | |
Hungary | 511.77.36003 Boehringer Ingelheim Investigational Site | Szeged | |
Hungary | 511.77.36004 Boehringer Ingelheim Investigational Site | Szentes | |
Italy | 511.77.39004 Ospedale S. Bambino | Catania | |
Italy | 511.77.39001 IRCCS S. Fondazione Maugeri | Pavia | |
Italy | 511.77.39002 Ospedale Santa Chiara | Pisa | |
Italy | 511.77.39003 Ospedale Sant'Anna | Torino | |
Netherlands | 511.77.31006 Boehringer Ingelheim Investigational Site | Almere | |
Netherlands | 511.77.31001 Boehringer Ingelheim Investigational Site | Amsterdam | |
Netherlands | 511.77.31004 Boehringer Ingelheim Investigational Site | Apeldoorn | |
Netherlands | 511.77.31009 Boehringer Ingelheim Investigational Site | Den Haag | |
Netherlands | 511.77.31007 Boehringer Ingelheim Investigational Site | Den Helder | |
Netherlands | 511.77.31005 Boehringer Ingelheim Investigational Site | Enschede | |
Netherlands | 511.77.31002 St Antonius ziekenhuis | Nieuwegein | |
Netherlands | 511.77.31008 Boehringer Ingelheim Investigational Site | Tilburg | |
Netherlands | 511.77.31003 Boehringer Ingelheim Investigational Site | Zeist | |
Norway | 511.77.47002 Boehringer Ingelheim Investigational Site | Lillestrøm | |
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 | Oslo | |
Spain | 511.77.34004 Boehringer Ingelheim Investigational Site | Barcelona | |
Spain | 511.77.34005 Boehringer Ingelheim Investigational Site | Barcelona | |
Spain | 511.77.34006 Boehringer Ingelheim Investigational Site | L´Hospitalet del LLobregat | |
Spain | 511.77.34003 Boehringer Ingelheim Investigational Site | Manresa (Barcelona) | |
Spain | 511.77.34002 Boehringer Ingelheim Investigational Site | Mataró-Barcelona | |
Spain | 511.77.34001 Boehringer Ingelheim Investigational Site | Orense | |
Sweden | 511.77.46004 Boehringer Ingelheim Investigational Site | Kungsbacka | |
Sweden | 511.77.46009 Boehringer Ingelheim Investigational Site | Lund | |
Sweden | 511.77.46007 Boehringer Ingelheim Investigational Site | Malmö | |
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 | Stockholm | |
Sweden | 511.77.46005 Boehringer Ingelheim Investigational Site | Uppsala | |
Sweden | 511.77.46003 Boehringer Ingelheim Investigational Site | Västerås | |
United Kingdom | 511.77.44011 Boehringer Ingelheim Investigational Site | Belfast | |
United Kingdom | 511.77.44009 Boehringer Ingelheim Investigational Site | Chorley | |
United Kingdom | 511.77.44004 Boehringer Ingelheim Investigational Site | Fisherwick, Lichfield | |
United Kingdom | 511.77.44008 Boehringer Ingelheim Investigational Site | Glasgow | |
United Kingdom | 511.77.44003 Boehringer Ingelheim Investigational Site | Headington, Oxford | |
United Kingdom | 511.77.44005 Boehringer Ingelheim Investigational Site | Leeds | |
United Kingdom | 511.77.44001 Boehringer Ingelheim Investigational Site | London | |
United Kingdom | 511.77.44002 Boehringer Ingelheim Investigational Site | London | |
United Kingdom | 511.77.44007 Boehringer Ingelheim Investigational Site | South Brent | |
United Kingdom | 511.77.44010 Boehringer Ingelheim Investigational Site | Waterloo, Liverpool |
Lead Sponsor | Collaborator |
---|---|
Sprout Pharmaceuticals, Inc |
Austria, Belgium, Czech Republic, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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?" | baseline to 24 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00996372 -
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
|
Phase 3 | |
Completed |
NCT00996164 -
Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
|
Phase 3 | |
Recruiting |
NCT05777031 -
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
|
Phase 4 | |
Completed |
NCT01188720 -
Sexual Health on Antidepressants Through Physical Exercise
|
N/A | |
Completed |
NCT00175539 -
Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties
|
N/A | |
Completed |
NCT04792177 -
Internet-based Emotion Regulation Intervention for Sexual Health
|
N/A | |
Completed |
NCT02381912 -
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer
|
N/A | |
Completed |
NCT03241524 -
Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women
|
N/A | |
Completed |
NCT00034021 -
Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
|
Phase 2 | |
Recruiting |
NCT05489133 -
Early Psychological Intervention After Rape
|
N/A | |
Completed |
NCT03775239 -
Mindfulness as Treatment of Sexological Problems
|
N/A | |
Completed |
NCT01654458 -
A Randomized Controlled Trial of an Online Support Group for Sexual Distress Due to Gynecologic Cancer
|
N/A | |
Completed |
NCT01188603 -
Pharmacokinetics of Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder (HSDD)
|
Phase 1 | |
Completed |
NCT01771237 -
HIV Prevention Among Vulnerable Male Youth
|
N/A | |
Completed |
NCT00360555 -
A Twenty Four Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
|
Phase 3 | |
Completed |
NCT00360243 -
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
|
Phase 3 | |
Completed |
NCT00360529 -
24-Week Placebo-Controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
|
Phase 3 | |
Recruiting |
NCT05456919 -
Quality of Sexual Function in BRCA Mutated Women
|
||
Terminated |
NCT01057901 -
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
|
Phase 3 | |
Terminated |
NCT01040208 -
12 Week Safety Trial of Flibanserin in Depressed Women Taking a Selective Serotonin Reuptake Inhibitor or Norepinephrine Serotonin Reuptake Inhibitor With Decreased Sexual Desire and Distress
|
Phase 3 |