Clinical trial NCT00360243: 6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2006-08-04
Enrollment: 1385
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline to 24 Weeks in the Frequency of Satisfying Sexual Events as Measured by the eDiary.
timeFrame: 24 weeks
measure: Change From Baseline to 24 Weeks in Responses to the eDiary Daily Desire Question.
timeFrame: baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: 511.70.01068 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 511.70.01040 Boehringer Ingelheim Investigational Site
state: Alabama
city: Tucson
country: United States
facility: 511.70.01041 Boehringer Ingelheim Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: 511.70.01003 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Carmichael
country: United States
facility: 511.70.01070 Boehringer Ingelheim Investigational Site
state: California
city: Redding
country: United States
facility: 511.70.01026 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.70.01015 Boehringer Ingelheim Investigational Site
state: California
city: Stanford
country: United States
facility: 511.70.01014 Boehringer Ingelheim Investigational Site
state: California
city: Tarzana
country: United States
facility: 511.70.01017 Boehringer Ingelheim Investigational Site
state: California
city: Torrance
country: United States
facility: 511.70.01072 Boehringer Ingelheim Investigational Site
state: California
city: Vista
country: United States
facility: 511.70.01078 Boehringer Ingelheim Investigational Site
state: California
city: Walnut Creek
country: United States
facility: 511.70.01066 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 511.70.01064 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheatridge
country: United States
facility: 511.70.01001 Boehringer Ingelheim Investigational Site
state: Colorado
city: Farmington
country: United States
facility: 511.70.01050 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: 511.70.01006 Boehringer Ingelheim Investigational Site
state: Connecticut
city: New London
country: United States
facility: 511.70.01055 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: 511.70.01024 Boehringer Ingelheim Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: 511.70.01056 Boehringer Ingelheim Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: 511.70.01090 Boehringer Ingelheim Investigational Site
state: Florida
city: Gainesville
country: United States
facility: 511.70.01027 Boehringer Ingelheim Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: 511.70.01062 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 511.70.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: 511.70.01084 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 511.70.01048 Boehringer Ingelheim Investigational Site
state: Florida
city: Stuart
country: United States
facility: 511.70.01042 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.70.01063 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.70.01085 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.70.01086 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 511.70.01022 Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: 511.70.01057 Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: 511.70.01087 Boehringer Ingelheim Investigational Site
state: Georgia
city: Roswell
country: United States
facility: 511.70.01052 Boehringer Ingelheim Investigational Site
state: Georgia
city: Champaign
country: United States
facility: 511.70.01060 Boehringer Ingelheim Investigational Site
state: Illinois
city: Chicago
country: United States
facility: 511.70.01058 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 511.70.01032 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lexington
country: United States
facility: 511.70.01018 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: 511.70.01007 Boehringer Ingelheim Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: 511.70.01047 Boehringer Ingelheim Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: 511.70.01079 Boehringer Ingelheim Investigational Site
state: Louisiana
city: St. Louis
country: United States
facility: 511.70.01031 Boehringer Ingelheim Investigational Site
state: Maryland
city: Haverhill
country: United States
facility: 511.70.01011 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: 511.70.01028 Boehringer Ingelheim Investigational Site
state: Michigan
city: Detroit
country: United States
facility: 511.70.01081 Boehringer Ingelheim Investigational Site
state: Michigan
city: Billings
country: United States
facility: 511.70.01082 Boehringer Ingelheim Investigational Site
state: Montana
city: Moorestown
country: United States
facility: 511.70.01077 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Endwell
country: United States
facility: 511.70.01019 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 511.70.01076 Boehringer Ingelheim Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: 511.70.01025 Boehringer Ingelheim Investigational Site
state: New York
city: Purchase
country: United States
facility: 511.70.01067 Boehringer Ingelheim Investigational Site
state: New York
city: Mount Airy
country: United States
facility: 511.70.01016 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 511.70.01044 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: 511.70.01049 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 511.70.01089 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.70.01054 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 511.70.01075 Boehringer Ingelheim Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: 511.70.01002 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 511.70.01065 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: 511.70.01083 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: 511.70.01036 Boehringer Ingelheim Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: 511.70.01004 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: 511.70.01021 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: 511.70.01073 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Anderson
country: United States
facility: 511.70.01023 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: 511.70.01035 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Nasville
country: United States
facility: 511.70.01008 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: 511.70.01020 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 511.70.01009 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.70.01030 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.70.01091 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.70.01013 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 511.70.01005 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 511.70.01061 Boehringer Ingelheim Investigational Site
state: Utah
city: Burlington
country: United States
facility: 511.70.01010 Boehringer Ingelheim Investigational Site
state: Vermont
city: Charlottesville
country: United States
facility: 511.70.01012 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 511.70.01046 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.70.01029 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.70.01071 Boehringer Ingelheim Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: 511.70.01033 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 511.70.01039 Boehringer Ingelheim Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: 511.70.01069 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: