6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

Sexual Dysfunctions, Psychological Clinical Trial

Official title:

6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360243
• Other study ID #: 511.70
• Status: Completed
• Phase: Phase 3
• First received: August 3, 2006
• Last updated: March 14, 2012
• Start date: July 2006

Study information

• Verified date: March 2012
• 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

This trial is designed to assess the safety and efficacy of flibanserin in the treatment of premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1392
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Women who are 18 years of age and older.

2. Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.

3. Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.

4. Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.

5. Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).

6. At the Baseline Visit, patients must have complied with eDiary use adequately.

7. 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 partner is expected to be physically present at least 50% of each month.

8. Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.

9. In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.

10. Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.

11. Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

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

2. Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.

3. Patients with a history of drug dependence or abuse within the past one year.

4. Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.

5. Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.

6. Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.

7. Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.

8. Patients who have entered the menopausal transition or menopause or have had a hysterectomy.

9. Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.

10. Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.

11. Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.

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
Experimental: flibanserin 25 mg b.i.d
• flibanserin
Experimental: flibanserin 50mg qhs
• flibanserin
Experimental: flibanserin 50mg b.i.d.
• placebo
placebo

Locations

Country	Name	City	State
United States	511.70.01023 Boehringer Ingelheim Investigational Site	Anderson	South Carolina
United States	511.70.01022 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.70.01057 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.70.01087 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.70.01024 Boehringer Ingelheim Investigational Site	Aventura	Florida
United States	511.70.01007 Boehringer Ingelheim Investigational Site	Baton Rouge	Louisiana
United States	511.70.01033 Boehringer Ingelheim Investigational Site	Bellevue	Washington
United States	511.70.01082 Boehringer Ingelheim Investigational Site	Billings	Montana
United States	511.70.01010 Boehringer Ingelheim Investigational Site	Burlington	Vermont
United States	511.70.01070 Boehringer Ingelheim Investigational Site	Carmichael	California
United States	511.70.01060 Boehringer Ingelheim Investigational Site	Champaign	Illinois
United States	511.70.01035 Boehringer Ingelheim Investigational Site	Charleston	South Carolina
United States	511.70.01012 Boehringer Ingelheim Investigational Site	Charlottesville	Virginia
United States	511.70.01058 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	511.70.01049 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.70.01089 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.70.01054 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.70.01020 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas
United States	511.70.01009 Boehringer Ingelheim Investigational Site	Dallas	Texas
United States	511.70.01075 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	511.70.01056 Boehringer Ingelheim Investigational Site	Daytona Beach	Florida
United States	511.70.01064 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	511.70.01028 Boehringer Ingelheim Investigational Site	Detroit	Michigan
United States	511.70.01081 Boehringer Ingelheim Investigational Site	Detroit	Michigan
United States	511.70.01019 Boehringer Ingelheim Investigational Site	Endwell	New York
United States	511.70.01050 Boehringer Ingelheim Investigational Site	Farmington	Connecticut
United States	511.70.01090 Boehringer Ingelheim Investigational Site	Ft. Lauderdale	Florida
United States	511.70.01027 Boehringer Ingelheim Investigational Site	Gainesville	Florida
United States	511.70.01006 Boehringer Ingelheim Investigational Site	Hartford	Connecticut
United States	511.70.01011 Boehringer Ingelheim Investigational Site	Haverhill	Massachusetts
United States	511.70.01030 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	511.70.01091 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	511.70.01068 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	511.70.01032 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana
United States	511.70.01003 Boehringer Ingelheim Investigational Site	Jonesboro	Arkansas
United States	511.70.01018 Boehringer Ingelheim Investigational Site	Lexington	Kentucky
United States	511.70.01002 Boehringer Ingelheim Investigational Site	Mayfield Heights	Ohio
United States	511.70.01036 Boehringer Ingelheim Investigational Site	Medford	Oregon
United States	511.70.01069 Boehringer Ingelheim Investigational Site	Milwaukee	Wisconsin
United States	511.70.01040 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	511.70.01077 Boehringer Ingelheim Investigational Site	Moorestown	New Jersey
United States	511.70.01016 Boehringer Ingelheim Investigational Site	Mount Airy	North Carolina
United States	511.70.01008 Boehringer Ingelheim Investigational Site	Nasville	Tennessee
United States	511.70.01055 Boehringer Ingelheim Investigational Site	New London	Connecticut
United States	511.70.01047 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	511.70.01079 Boehringer Ingelheim Investigational Site	New Orleans	Louisiana
United States	511.70.01062 Boehringer Ingelheim Investigational Site	New Port Richey	Florida
United States	511.70.01076 Boehringer Ingelheim Investigational Site	New York	New York
United States	511.70.01046 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	511.70.01043 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	511.70.01084 Boehringer Ingelheim Investigational Site	Pembroke Pines	Florida
United States	511.70.01004 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania
United States	511.70.01025 Boehringer Ingelheim Investigational Site	Poughkeepsie	New York
United States	511.70.01067 Boehringer Ingelheim Investigational Site	Purchase	New York
United States	511.70.01044 Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	511.70.01026 Boehringer Ingelheim Investigational Site	Redding	California
United States	511.70.01029 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.70.01071 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.70.01052 Boehringer Ingelheim Investigational Site	Roswell	Georgia
United States	511.70.01005 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	511.70.01013 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.70.01015 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.70.01061 Boehringer Ingelheim Investigational Site	Sandy	Utah
United States	511.70.01031 Boehringer Ingelheim Investigational Site	St. Louis	Maryland
United States	511.70.01048 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida
United States	511.70.01014 Boehringer Ingelheim Investigational Site	Stanford	California
United States	511.70.01042 Boehringer Ingelheim Investigational Site	Stuart	Florida
United States	511.70.01039 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	511.70.01063 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.70.01085 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.70.01017 Boehringer Ingelheim Investigational Site	Tarzana	California
United States	511.70.01072 Boehringer Ingelheim Investigational Site	Torrance	California
United States	511.70.01041 Boehringer Ingelheim Investigational Site	Tucson	Arizona
United States	511.70.01065 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	511.70.01083 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	511.70.01078 Boehringer Ingelheim Investigational Site	Vista	California
United States	511.70.01066 Boehringer Ingelheim Investigational Site	Walnut Creek	California
United States	511.70.01073 Boehringer Ingelheim Investigational Site	Warwick	Rhode Island
United States	511.70.01086 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	511.70.01021 Boehringer Ingelheim Investigational Site	West Reading	Pennsylvania
United States	511.70.01001 Boehringer Ingelheim Investigational Site	Wheatridge	Colorado

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	change from baseline in the frequency of satisfying sexual events as measured by the eDiary and the change from baseline in the monthly sum of responses to the eDiary daily desire question (Week 21 to 24).		24 weeks	No
Secondary	FSDS R© which quantifies the change in personal distress due to sexual dysfunction.		24 weeks	No