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

Sexual Dysfunctions, Psychological Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996164
• Other study ID #: 511.147
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: April 16, 2014
• Start date: October 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2014
• Source: Sprout Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1090
• Est. completion date: February 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Flibanserin
patients will be randomized to flibanserin or placebo in a double-blind manner
• Placebo
patients will be randomized to flibanserin or placebo in a double-blind manner

Locations

Country	Name	City	State
United States	511.147.01009 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.147.01023 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.147.01013 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	511.147.01014 Boehringer Ingelheim Investigational Site	Billings	Montana
United States	511.147.01031 Boehringer Ingelheim Investigational Site	Bingham Farms	Michigan
United States	511.147.01074 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	511.147.01003 Boehringer Ingelheim Investigational Site	Boynton Beach	Florida
United States	511.147.01044 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	511.147.01033 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.147.01056 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	511.147.01004 Boehringer Ingelheim Investigational Site	Cleveland	Ohio
United States	511.147.01048 Boehringer Ingelheim Investigational Site	Columbia	South Carolina
United States	511.147.01050 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.147.01059 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.147.01018 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas
United States	511.147.01058 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	511.147.01065 Boehringer Ingelheim Investigational Site	Daytona Beach	Florida
United States	511.147.01071 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	511.147.01030 Boehringer Ingelheim Investigational Site	Encinitas	California
United States	511.147.01017 Boehringer Ingelheim Investigational Site	Endwell	New York
United States	511.147.01007 Boehringer Ingelheim Investigational Site	Eugene	Oregon
United States	511.147.01028 Boehringer Ingelheim Investigational Site	Fair Oaks	California
United States	511.147.01053 Boehringer Ingelheim Investigational Site	Farmington	Connecticut
United States	511.147.01015 Boehringer Ingelheim Investigational Site	Groton	Connecticut
United States	511.147.01032 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	511.147.01046 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	511.147.01034 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana
United States	511.147.01037 Boehringer Ingelheim Investigational Site	Irvine	California
United States	511.147.01011 Boehringer Ingelheim Investigational Site	Katy	Texas
United States	511.147.01063 Boehringer Ingelheim Investigational Site	Knoxville	Tennessee
United States	511.147.01067 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana
United States	511.147.01057 Boehringer Ingelheim Investigational Site	Las Vegas	Nevada
United States	511.147.01020 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	511.147.01024 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	511.147.01042 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	511.147.01039 Boehringer Ingelheim Investigational Site	Moorestown	New Jersey
United States	511.147.01068 Boehringer Ingelheim Investigational Site	Mt. Pleasant	South Carolina
United States	511.147.01010 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	511.147.01036 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	511.147.01047 Boehringer Ingelheim Investigational Site	New Bern	North Carolina
United States	511.147.01041 Boehringer Ingelheim Investigational Site	New Britain	Connecticut
United States	511.147.01070 Boehringer Ingelheim Investigational Site	New Port Richey	Florida
United States	511.147.01064 Boehringer Ingelheim Investigational Site	Newark	Delaware
United States	511.147.01040 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	511.147.01049 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	511.147.01072 Boehringer Ingelheim Investigational Site	Oklahoma City	Oklahoma
United States	511.147.01060 Boehringer Ingelheim Investigational Site	Omaha	Nebraska
United States	511.147.01043 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	511.147.01025 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	511.147.01073 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	511.147.01055 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	511.147.01054 Boehringer Ingelheim Investigational Site	Renton	Washington
United States	511.147.01029 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.147.01075 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.147.01022 Boehringer Ingelheim Investigational Site	Sacramento	California
United States	511.147.01005 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	511.147.01012 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.147.01026 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.147.01035 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.147.01052 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.147.01069 Boehringer Ingelheim Investigational Site	Sandy	Utah
United States	511.147.01008 Boehringer Ingelheim Investigational Site	Sandy Springs	Georgia
United States	511.147.01045 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	511.147.01006 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	511.147.01019 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida
United States	511.147.01038 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	511.147.01061 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.147.01066 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.147.01016 Boehringer Ingelheim Investigational Site	Torrance	California
United States	511.147.01021 Boehringer Ingelheim Investigational Site	Vista	California
United States	511.147.01062 Boehringer Ingelheim Investigational Site	Washington	District of Columbia
United States	511.147.01001 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	511.147.01002 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	511.147.01051 Boehringer Ingelheim Investigational Site	Westlake Village	California
United States	511.147.01027 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sprout Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change From Baseline to Week 24 in the Score of the Female Sexual Function Index Desire Domain.	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.	24 weeks	No
Primary	Change From Baseline in the SSE Count From Baseline to 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.	24 weeks	No