Flibanserin Versus Placebo in Premenopausal Women With HSDD
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Frequency of Satisfying Sexual Events as Measured by the eDiary. [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?"
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 511.77.43005 Boehringer Ingelheim Investigational Site | Innsbruck | Austria | ||
| 2 | 511.77.43001 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 3 | 511.77.43002 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 4 | 511.77.43004 Boehringer Ingelheim Investigational Site | Wien | Austria | ||
| 5 | 511.77.43006 Boehringer Ingelheim Investigational Site | Wörgl | Austria | ||
| 6 | 511.77.32004 Boehringer Ingelheim Investigational Site | Braine-l'Alleud | Belgium | ||
| 7 | 511.77.32003 Boehringer Ingelheim Investigational Site | Edegem | Belgium | ||
| 8 | 511.77.32005 Boehringer Ingelheim Investigational Site | Gent | Belgium | ||
| 9 | 511.77.32006 Boehringer Ingelheim Investigational Site | Hasselt | Belgium | ||
| 10 | 511.77.32002 Boehringer Ingelheim Investigational Site | Yvoir | Belgium | ||
| 11 | 511.77.42001 Boehringer Ingelheim Investigational Site | Olomouc | Czech Republic | ||
| 12 | 511.77.42002 Boehringer Ingelheim Investigational Site | Prague | Czech Republic | ||
| 13 | 511.77.42003 Boehringer Ingelheim Investigational Site | Prague | Czech Republic | ||
| 14 | 511.77.42004 Boehringer Ingelheim Investigational Site | Vresina | Czech Republic | ||
| 15 | 511.77.35801 Boehringer Ingelheim Investigational Site | Espoo | Finland | ||
| 16 | 511.77.35805 Boehringer Ingelheim Investigational Site | Helsinki | Finland | ||
| 17 | 511.77.35802 Boehringer Ingelheim Investigational Site | Oulu | Finland | ||
| 18 | 511.77.35803 Boehringer Ingelheim Investigational Site | Seinäjoki | Finland | ||
| 19 | 511.77.35804 Boehringer Ingelheim Investigational Site | Tampere | Finland | ||
| 20 | 511.77.3308A Boehringer Ingelheim Investigational Site | Blanquefort | France | ||
| 21 | 511.77.3301A Boehringer Ingelheim Investigational Site | Bordeaux | France | ||
| 22 | 511.77.3305A Boehringer Ingelheim Investigational Site | La Rochelle | France | ||
| 23 | 511.77.3314A Boehringer Ingelheim Investigational Site | Lille | France | ||
| 24 | 511.77.3314B Cabinet médical | Lille | France | ||
| 25 | 511.77.3314C Cabinet médical | Lille | France | ||
| 26 | 511.77.3303A Boehringer Ingelheim Investigational Site | Marseille Cedex 9 | France | ||
| 27 | 511.77.3310A Boehringer Ingelheim Investigational Site | Marseille | France | ||
| 28 | 511.77.3312A Boehringer Ingelheim Investigational Site | Marseille | France | ||
| 29 | 511.77.3302A Boehringer Ingelheim Investigational Site | Paris | France | ||
| 30 | 511.77.3315A Cabinet Médical | Rennes | France | ||
| 31 | 511.77.3306A Boehringer Ingelheim Investigational Site | Saint Emilion | France | ||
| 32 | 511.77.3311A Boehringer Ingelheim Investigational Site | Toulouse | France | ||
| 33 | 511.77.49004 Boehringer Ingelheim Investigational Site | Berlin | Germany | ||
| 34 | 511.77.49007 Boehringer Ingelheim Investigational Site | Bochum | Germany | ||
| 35 | 511.77.49001 Boehringer Ingelheim Investigational Site | Bonn | Germany | ||
| 36 | 511.77.49006 Boehringer Ingelheim Investigational Site | Dresden | Germany | ||
| 37 | 511.77.49008 Boehringer Ingelheim Investigational Site | Frankfurt | Germany | ||
| 38 | 511.77.49003 Boehringer Ingelheim Investigational Site | Freiburg | Germany | ||
| 39 | 511.77.49002 Boehringer Ingelheim Investigational Site | Hannover | Germany | ||
| 40 | 511.77.49005 Boehringer Ingelheim Investigational Site | Leipzig | Germany | ||
| 41 | 511.77.49009 Boehringer Ingelheim Investigational Site | Magdeburg | Germany | ||
| 42 | 511.77.36001 Boehringer Ingelheim Investigational Site | Budapest | Hungary | ||
| 43 | 511.77.36005 Boehringer Ingelheim Investigational Site | Kecskemét | Hungary | ||
| 44 | 511.77.36003 Boehringer Ingelheim Investigational Site | Szeged | Hungary | ||
| 45 | 511.77.36004 Boehringer Ingelheim Investigational Site | Szentes | Hungary | ||
| 46 | 511.77.39004 Ospedale S. Bambino | Catania | Italy | ||
| 47 | 511.77.39001 IRCCS S. Fondazione Maugeri | Pavia | Italy | ||
| 48 | 511.77.39002 Ospedale Santa Chiara | Pisa | Italy | ||
| 49 | 511.77.39003 Ospedale Sant'Anna | Torino | Italy | ||
| 50 | 511.77.31006 Boehringer Ingelheim Investigational Site | Almere | Netherlands | ||
| 51 | 511.77.31001 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands | ||
| 52 | 511.77.31004 Boehringer Ingelheim Investigational Site | Apeldoorn | Netherlands | ||
| 53 | 511.77.31009 Boehringer Ingelheim Investigational Site | Den Haag | Netherlands | ||
| 54 | 511.77.31007 Boehringer Ingelheim Investigational Site | Den Helder | Netherlands | ||
| 55 | 511.77.31005 Boehringer Ingelheim Investigational Site | Enschede | Netherlands | ||
| 56 | 511.77.31002 St Antonius ziekenhuis | Nieuwegein | Netherlands | ||
| 57 | 511.77.31008 Boehringer Ingelheim Investigational Site | Tilburg | Netherlands | ||
| 58 | 511.77.31003 Boehringer Ingelheim Investigational Site | Zeist | Netherlands | ||
| 59 | 511.77.47002 Boehringer Ingelheim Investigational Site | Lillestrøm | Norway | ||
| 60 | 511.77.47001 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 61 | 511.77.47003 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 62 | 511.77.47004 Boehringer Ingelheim Investigational Site | Oslo | Norway | ||
| 63 | 511.77.34004 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 64 | 511.77.34005 Boehringer Ingelheim Investigational Site | Barcelona | Spain | ||
| 65 | 511.77.34006 Boehringer Ingelheim Investigational Site | L´Hospitalet del LLobregat | Spain | ||
| 66 | 511.77.34003 Boehringer Ingelheim Investigational Site | Manresa (Barcelona) | Spain | ||
| 67 | 511.77.34002 Boehringer Ingelheim Investigational Site | Mataró-Barcelona | Spain | ||
| 68 | 511.77.34001 Boehringer Ingelheim Investigational Site | Orense | Spain | ||
| 69 | 511.77.46004 Boehringer Ingelheim Investigational Site | Kungsbacka | Sweden | ||
| 70 | 511.77.46009 Boehringer Ingelheim Investigational Site | Lund | Sweden | ||
| 71 | 511.77.46007 Boehringer Ingelheim Investigational Site | Malmö | Sweden | ||
| 72 | 511.77.46001 Junoenheten/Kvinnohälsan, Kvinnokliniken | Stockholm | Sweden | ||
| 73 | 511.77.46002 Boehringer Ingelheim Investigational Site | Stockholm | Sweden | ||
| 74 | 511.77.46006 Boehringer Ingelheim Investigational Site | Stockholm | Sweden | ||
| 75 | 511.77.46005 Boehringer Ingelheim Investigational Site | Uppsala | Sweden | ||
| 76 | 511.77.46003 Boehringer Ingelheim Investigational Site | Västerås | Sweden | ||
| 77 | 511.77.44011 Boehringer Ingelheim Investigational Site | Belfast | United Kingdom | ||
| 78 | 511.77.44009 Boehringer Ingelheim Investigational Site | Chorley | United Kingdom | ||
| 79 | 511.77.44004 Boehringer Ingelheim Investigational Site | Fisherwick, Lichfield | United Kingdom | ||
| 80 | 511.77.44008 Boehringer Ingelheim Investigational Site | Glasgow | United Kingdom | ||
| 81 | 511.77.44003 Boehringer Ingelheim Investigational Site | Headington, Oxford | United Kingdom | ||
| 82 | 511.77.44005 Boehringer Ingelheim Investigational Site | Leeds | United Kingdom | ||
| 83 | 511.77.44001 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 84 | 511.77.44002 Boehringer Ingelheim Investigational Site | London | United Kingdom | ||
| 85 | 511.77.44007 Boehringer Ingelheim Investigational Site | South Brent | United Kingdom | ||
| 86 | 511.77.44010 Boehringer Ingelheim Investigational Site | Waterloo, Liverpool | United Kingdom |
Sponsors and Collaborators
- Sprout Pharmaceuticals, Inc
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 511.77
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Flibanserin 50mg | Flibanserin 100mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 50 mg qhs BIMT 17 BS 50 mg: flibanserin 50 mg | 100 mg qhs BIMT 17 BS 100 mg: flibanserin 100mg | placebo qhs placebo: placebo |
| Period Title: Overall Study | |||
| STARTED | 311 | 316 | 318 |
| COMPLETED | 216 | 202 | 243 |
| NOT COMPLETED | 95 | 114 | 75 |
Baseline Characteristics
| Arm/Group Title | Flibanserin 50mg | Flibanserin 100mg | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | 50 mg qhs BIMT 17 BS 50 mg: flibanserin 50 mg | 100 mg qhs BIMT 17 BS 100 mg: flibanserin 100mg | placebo qhs placebo: placebo | Total of all reporting groups |
| Overall Participants | 311 | 316 | 318 | 945 |
| Age, Customized (participants) [Number] | ||||
| 18-34 years |
145
46.6%
|
128
40.5%
|
148
46.5%
|
421
44.6%
|
| 35-44 years |
133
42.8%
|
157
49.7%
|
147
46.2%
|
437
46.2%
|
| 45 years and older |
33
10.6%
|
31
9.8%
|
23
7.2%
|
87
9.2%
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
311
100%
|
316
100%
|
318
100%
|
945
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | ||||
| White |
276
88.7%
|
281
88.9%
|
286
89.9%
|
843
89.2%
|
| White Hispanic |
6
1.9%
|
9
2.8%
|
3
0.9%
|
18
1.9%
|
| Black |
2
0.6%
|
3
0.9%
|
3
0.9%
|
8
0.8%
|
| Black Hispanic |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
0.3%
|
1
0.3%
|
0
0%
|
2
0.2%
|
| Asian Hispanic |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Missing |
26
8.4%
|
22
7%
|
26
8.2%
|
74
7.8%
|
| Region of Enrollment (participants) [Number] | ||||
| Finland |
18
5.8%
|
17
5.4%
|
18
5.7%
|
53
5.6%
|
| Spain |
5
1.6%
|
8
2.5%
|
2
0.6%
|
15
1.6%
|
| Austria |
16
5.1%
|
20
6.3%
|
19
6%
|
55
5.8%
|
| Italy |
10
3.2%
|
9
2.8%
|
10
3.1%
|
29
3.1%
|
| United Kingdom |
31
10%
|
34
10.8%
|
35
11%
|
100
10.6%
|
| France |
27
8.7%
|
27
8.5%
|
28
8.8%
|
82
8.7%
|
| Hungary |
19
6.1%
|
18
5.7%
|
18
5.7%
|
55
5.8%
|
| Czech Republic |
22
7.1%
|
20
6.3%
|
21
6.6%
|
63
6.7%
|
| Belgium |
27
8.7%
|
27
8.5%
|
28
8.8%
|
82
8.7%
|
| Netherlands |
30
9.6%
|
32
10.1%
|
34
10.7%
|
96
10.2%
|
| Norway |
11
3.5%
|
13
4.1%
|
10
3.1%
|
34
3.6%
|
| Germany |
56
18%
|
54
17.1%
|
55
17.3%
|
165
17.5%
|
| Sweden |
39
12.5%
|
37
11.7%
|
40
12.6%
|
116
12.3%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients who had at least one post-dose on-treatment efficacy assessment were included in the Full Analysis Set (FAS). The FAS was used for primary analyses. |
| Arm/Group Title | Flibanserin 50mg | Flibanserin 100mg | Placebo |
|---|---|---|---|
| Arm/Group Description | 50 mg qhs BIMT 17 BS 50 mg: flibanserin 50 mg | 100 mg qhs BIMT 17 BS 100 mg: flibanserin 100mg | placebo qhs placebo: placebo |
| Measure Participants | 297 | 299 | 307 |
| Mean (Standard Deviation) [events per month] |
1.2
(3.7)
|
1.5
(4.0)
|
0.9
(3.2)
|
Adverse Events
| Time Frame | ||||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Flibanserin 50mg | Flibanserin 100mg | Placebo | |||
| Arm/Group Description | 50 mg qhs BIMT 17 BS 50 mg: flibanserin 50 mg | 100 mg qhs BIMT 17 BS 100 mg: flibanserin 100mg | placebo qhs placebo: placebo | |||
All Cause Mortality |
||||||
| Flibanserin 50mg | Flibanserin 100mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Flibanserin 50mg | Flibanserin 100mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 25/311 (8%) | 19/316 (6%) | 16/318 (5%) | |||
| Gastrointestinal disorders | ||||||
| abdominal pain | 9/311 (2.9%) | 12 | 6/316 (1.9%) | 6 | 6/318 (1.9%) | 6 |
| subileus | 0/311 (0%) | 0 | 1/316 (0.3%) | 1 | 0/318 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| cholelithiasis | 0/311 (0%) | 0 | 0/316 (0%) | 0 | 1/318 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| thoracic vertebral fracture | 1/311 (0.3%) | 1 | 0/316 (0%) | 0 | 0/318 (0%) | 0 |
| concussion | 1/311 (0.3%) | 1 | 1/316 (0.3%) | 1 | 0/318 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| intervertebral disc protrusion | 2/311 (0.6%) | 3 | 0/316 (0%) | 0 | 0/318 (0%) | 0 |
| Nervous system disorders | ||||||
| gliosis | 1/311 (0.3%) | 1 | 0/316 (0%) | 0 | 0/318 (0%) | 0 |
| Psychiatric disorders | ||||||
| suicide attempt | 0/311 (0%) | 0 | 1/316 (0.3%) | 1 | 0/318 (0%) | 0 |
| Renal and urinary disorders | ||||||
| haematuria | 0/311 (0%) | 0 | 0/316 (0%) | 0 | 1/318 (0.3%) | 1 |
| Reproductive system and breast disorders | ||||||
| ovarian cyst ruptured | 0/311 (0%) | 0 | 0/316 (0%) | 0 | 1/318 (0.3%) | 1 |
| metrorrhagia | 12/311 (3.9%) | 14 | 9/316 (2.8%) | 13 | 6/318 (1.9%) | 9 |
| Vascular disorders | ||||||
| circulatory collapse | 0/311 (0%) | 0 | 1/316 (0.3%) | 1 | 1/318 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Flibanserin 50mg | Flibanserin 100mg | Placebo | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 174/311 (55.9%) | 238/316 (75.3%) | 143/318 (45%) | |||
| Gastrointestinal disorders | ||||||
| nausea | 19/311 (6.1%) | 20 | 39/316 (12.3%) | 49 | 19/318 (6%) | 20 |
| General disorders | ||||||
| Fatigue | 35/311 (11.3%) | 41 | 54/316 (17.1%) | 67 | 33/318 (10.4%) | 36 |
| Infections and infestations | ||||||
| nasopharyngitis | 36/311 (11.6%) | 45 | 30/316 (9.5%) | 35 | 32/318 (10.1%) | 37 |
| Nervous system disorders | ||||||
| Headache | 49/311 (15.8%) | 91 | 53/316 (16.8%) | 66 | 42/318 (13.2%) | 67 |
| Dizziness | 23/311 (7.4%) | 25 | 46/316 (14.6%) | 55 | 14/318 (4.4%) | 16 |
| Somnolence | 12/311 (3.9%) | 12 | 16/316 (5.1%) | 17 | 3/318 (0.9%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Scientific Program Director |
|---|---|
| Organization | Sprout Pharmaceuticals |
| Phone | 9198820850 |
| clinicaltrials@sproutpharma.com |
- 511.77