Fixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

• Sponsor: Sprout Pharmaceuticals, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00996164
• Collaborator: (none)
• Enrollment: 1,090
• Locations: 75
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 14.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The object of this trial is to assess the safety and efficacy of a 24 week course of flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunctions, Psychological	Drug: Flibanserin; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1090 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Twenty-four Week, Randomized, Double-blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin (100 Milligrams) Administered Orally Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder in the United States
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: flibanserin 100 mg flibanserin 100mg po qd	Drug: Flibanserin; patients will be randomized to flibanserin or placebo in a double-blind manner
Placebo Comparator: Placebo placebo 1 tab po qd	Drug: Placebo; patients will be randomized to flibanserin or placebo in a double-blind manner

Outcome Measures

Primary Outcome Measures

1. The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain. [24 weeks]

   The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.

2. Change From Baseline in the SSE Count From Baseline to 24 Weeks [24 weeks]

   The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question. An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion criteria:

1. Premenopausal women who are 18 years old and older

2. Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.

3. Stable, monogamous heterosexual relationship for at least one year.

4. Willing to discuss sexual issues.

5. Willing to engage in sexual activity at least once a month

6. Normal pap smear

7. Must use medically acceptable method of contraception

8. Able to comply with daily use of a handheld entry device

Exclusion criteria:

1. Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.

2. Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.

3. Partner with inadequately treated organic or psychosexual dysfunction

4. History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.

5. Sexual function impaired by psychiatric disorder

6. Sexual function impaired by gynecological disorder

7. Major life stress that could impair sexual function

8. Substance abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	511.147.01074 Boehringer Ingelheim Investigational Site	Birmingham	Alabama	United States
2	511.147.01046 Boehringer Ingelheim Investigational Site	Huntsville	Alabama	United States
3	511.147.01042 Boehringer Ingelheim Investigational Site	Mobile	Alabama	United States
4	511.147.01025 Boehringer Ingelheim Investigational Site	Phoenix	Arizona	United States
5	511.147.01073 Boehringer Ingelheim Investigational Site	Phoenix	Arizona	United States
6	511.147.01030 Boehringer Ingelheim Investigational Site	Encinitas	California	United States
7	511.147.01028 Boehringer Ingelheim Investigational Site	Fair Oaks	California	United States
8	511.147.01037 Boehringer Ingelheim Investigational Site	Irvine	California	United States
9	511.147.01022 Boehringer Ingelheim Investigational Site	Sacramento	California	United States
10	511.147.01035 Boehringer Ingelheim Investigational Site	San Diego	California	United States
11	511.147.01052 Boehringer Ingelheim Investigational Site	San Diego	California	United States
12	511.147.01016 Boehringer Ingelheim Investigational Site	Torrance	California	United States
13	511.147.01021 Boehringer Ingelheim Investigational Site	Vista	California	United States
14	511.147.01051 Boehringer Ingelheim Investigational Site	Westlake Village	California	United States
15	511.147.01071 Boehringer Ingelheim Investigational Site	Denver	Colorado	United States
16	511.147.01053 Boehringer Ingelheim Investigational Site	Farmington	Connecticut	United States
17	511.147.01015 Boehringer Ingelheim Investigational Site	Groton	Connecticut	United States
18	511.147.01041 Boehringer Ingelheim Investigational Site	New Britain	Connecticut	United States
19	511.147.01064 Boehringer Ingelheim Investigational Site	Newark	Delaware	United States
20	511.147.01062 Boehringer Ingelheim Investigational Site	Washington	District of Columbia	United States
21	511.147.01003 Boehringer Ingelheim Investigational Site	Boynton Beach	Florida	United States
22	511.147.01056 Boehringer Ingelheim Investigational Site	Clearwater	Florida	United States
23	511.147.01065 Boehringer Ingelheim Investigational Site	Daytona Beach	Florida	United States
24	511.147.01020 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
25	511.147.01024 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
26	511.147.01070 Boehringer Ingelheim Investigational Site	New Port Richey	Florida	United States
27	511.147.01043 Boehringer Ingelheim Investigational Site	Orlando	Florida	United States
28	511.147.01019 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida	United States
29	511.147.01061 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
30	511.147.01066 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
31	511.147.01001 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida	United States
32	511.147.01002 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida	United States
33	511.147.01009 Boehringer Ingelheim Investigational Site	Atlanta	Georgia	United States
34	511.147.01023 Boehringer Ingelheim Investigational Site	Atlanta	Georgia	United States
35	511.147.01008 Boehringer Ingelheim Investigational Site	Sandy Springs	Georgia	United States
36	511.147.01044 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
37	511.147.01034 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana	United States
38	511.147.01067 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana	United States
39	511.147.01013 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
40	511.147.01031 Boehringer Ingelheim Investigational Site	Bingham Farms	Michigan	United States
41	511.147.01006 Boehringer Ingelheim Investigational Site	St. Louis	Missouri	United States
42	511.147.01014 Boehringer Ingelheim Investigational Site	Billings	Montana	United States
43	511.147.01060 Boehringer Ingelheim Investigational Site	Omaha	Nebraska	United States
44	511.147.01057 Boehringer Ingelheim Investigational Site	Las Vegas	Nevada	United States
45	511.147.01039 Boehringer Ingelheim Investigational Site	Moorestown	New Jersey	United States
46	511.147.01017 Boehringer Ingelheim Investigational Site	Endwell	New York	United States
47	511.147.01047 Boehringer Ingelheim Investigational Site	New Bern	North Carolina	United States
48	511.147.01027 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina	United States
49	511.147.01033 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio	United States
50	511.147.01004 Boehringer Ingelheim Investigational Site	Cleveland	Ohio	United States
51	511.147.01050 Boehringer Ingelheim Investigational Site	Columbus	Ohio	United States
52	511.147.01059 Boehringer Ingelheim Investigational Site	Columbus	Ohio	United States
53	511.147.01058 Boehringer Ingelheim Investigational Site	Dayton	Ohio	United States
54	511.147.01072 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma	United States
55	511.147.01007 Boehringer Ingelheim Investigational Site	Eugene	Oregon	United States
56	511.147.01055 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania	United States
57	511.147.01048 Boehringer Ingelheim Investigational Site	Columbia	South Carolina	United States
58	511.147.01068 Boehringer Ingelheim Investigational Site	Mt. Pleasant	South Carolina	United States
59	511.147.01063 Boehringer Ingelheim Investigational Site	Knoxville	Tennessee	United States
60	511.147.01010 Boehringer Ingelheim Investigational Site	Nashville	Tennessee	United States
61	511.147.01036 Boehringer Ingelheim Investigational Site	Nashville	Tennessee	United States
62	511.147.01018 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas	United States
63	511.147.01032 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
64	511.147.01011 Boehringer Ingelheim Investigational Site	Katy	Texas	United States
65	511.147.01012 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
66	511.147.01026 Boehringer Ingelheim Investigational Site	San Antonio	Texas	United States
67	511.147.01005 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah	United States
68	511.147.01069 Boehringer Ingelheim Investigational Site	Sandy	Utah	United States
69	511.147.01040 Boehringer Ingelheim Investigational Site	Norfolk	Virginia	United States
70	511.147.01049 Boehringer Ingelheim Investigational Site	Norfolk	Virginia	United States
71	511.147.01029 Boehringer Ingelheim Investigational Site	Richmond	Virginia	United States
72	511.147.01075 Boehringer Ingelheim Investigational Site	Richmond	Virginia	United States
73	511.147.01054 Boehringer Ingelheim Investigational Site	Renton	Washington	United States
74	511.147.01045 Boehringer Ingelheim Investigational Site	Spokane	Washington	United States
75	511.147.01038 Boehringer Ingelheim Investigational Site	Tacoma	Washington	United States

Sponsors and Collaborators

• Sprout Pharmaceuticals, Inc

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sprout Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT00996164
• Other Study ID Numbers: 511.147
• First Posted: Oct 16, 2009
• Last Update Posted: May 19, 2014
• Last Verified: Apr 1, 2014

• Additional relevant MeSH terms: Sexual Dysfunctions, Psychological

Study Results

Participant Flow

Arm/Group Title	Flibanserin 100 mg	Placebo
Arm/Group Description	flibanserin 100mg po qd	placebo 1 tab po qd
Period Title: Overall Study
STARTED	543	547
COMPLETED	408	446
NOT COMPLETED	135	101

Baseline Characteristics

Arm/Group Title	Flibanserin 100 mg	Placebo	Total
Arm/Group Description	flibanserin 100mg po qd	placebo 1 tab po qd	Total of all reporting groups
Overall Participants	543	547	1090
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	543 100%	547 100%	1090 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.5 (7.8)	36.6 (8.0)	36.5 (7.3)
Sex: Female, Male (Count of Participants)
Female	543 100%	547 100%	1090 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	543 100%	547 100%	1090 100%

Outcome Measures

1. Primary Outcome

Title	The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.
Description	The FSFI is a self-administered questionnaire for assessing key dimensions of sexual function in women. The scale consists of 19 items assessing sexual function over the past 4 weeks and yields scores in 6 domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The 2 items in the desire domain are scored from '1' to '5'. The raw scores of the 2 items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 to 6.0. The higher the score on the desire domain, the higher the level of reported sexual desire.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.

Arm/Group Title	Flibanserin 100 mg	Placebo
Arm/Group Description	flibanserin 100mg po qd Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner	placebo 1 tab po qd Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner
Measure Participants	506	525
Mean (Standard Error) [units on a scale]	1.0 (0.1)	0.7 (0.1)

2. Primary Outcome

Title	Change From Baseline in the SSE Count From Baseline to 24 Weeks
Description	The change from baseline in the number of Satisfying Sexual Events (SSEs) as measured by the eDiary. The SSEs will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question. An eDiary was used by the patients to record information about sexual events. Patients were instructed to complete the eDiary every morning. When completing an eDiary entry, patients answered questions regarding their sexual events since their last eDiary entry. If patients missed or were late with their eDiary entry, they entered information about their sexual events covering a maximum time period of the past 7 days; however, they did not enter any information beyond the last entry.
Time Frame	24 weeks

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) consisted of those patients who were randomized to a treatment group, received at least one dose of study medication, and had at least one on-treatment efficacy assessment. The treated set was analyzed for safety. The FAS was analyzed for efficacy.

Arm/Group Title	Flibanserin 100 mg	Placebo
Arm/Group Description	flibanserin 100mg po qd Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner	placebo 1 tab po qd Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner
Measure Participants	500	521
Mean (Standard Deviation) [SSEs]	2.5 (4.6)	1.5 (4.5)

Adverse Events

Arm/Group Title	Flibanserin 100 mg		Placebo
Arm/Group Description	flibanserin 100mg po qd		placebo 1 tab po qd
All Cause Mortality
	Flibanserin 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Flibanserin 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/543 (0.7%)		2/547 (0.4%)
Gastrointestinal disorders
upper gastrointestinal hemorrhage	0/543 (0%)	0	1/547 (0.2%)	1
Hepatobiliary disorders
biliary dyskinesia	1/543 (0.2%)	1	0/547 (0%)	0
cholelithiasis	1/543 (0.2%)	1	0/547 (0%)	0
Infections and infestations
gastroenteritis	1/543 (0.2%)	1	0/547 (0%)	0
Injury, poisoning and procedural complications
cervical vertebral fracture	1/543 (0.2%)	1	0/547 (0%)	0
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain	1/543 (0.2%)	1	0/547 (0%)	0
Psychiatric disorders
suicidal ideation	0/543 (0%)	0	1/547 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
asthma	1/543 (0.2%)	1	0/547 (0%)	0
Other (Not Including Serious) Adverse Events
	Flibanserin 100 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	237/543 (43.6%)		68/547 (12.4%)
Gastrointestinal disorders
nausea	41/543 (7.6%)	44	12/547 (2.2%)	12
Nervous system disorders
somnolence	78/543 (14.4%)	81	19/547 (3.5%)	19
dizziness	56/543 (10.3%)	62	6/547 (1.1%)	6
fatigue	32/543 (5.9%)	32	18/547 (3.3%)	18
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection	30/543 (5.5%)	31	13/547 (2.4%)	14

Limitations/Caveats

[Not Specified]

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.