Clinical trial NCT00360555: Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
Official title: Best Tolerability: 50mg Twice Daily Versus 100 mg in the Evening Versus 25 mg Twice Daily Versus Placebo in Younger Women in North America
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: 1584
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
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 meets 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.
12. A score of 15 or higher on the FSDS-R at 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.
12. Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
13. Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
14. Patients who have started psychotherapy

Primary outcomes:
measure: Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary.
timeFrame: baseline to 28 weeks
measure: Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question.
timeFrame: baseline to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 511.75.01015 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 511.75.01028 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 511.75.01051 Boehringer Ingelheim Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: 511.75.01063 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Berkeley
country: United States
facility: 511.75.01017 Boehringer Ingelheim Investigational Site
state: California
city: Encinitas
country: United States
facility: 511.75.01014 Boehringer Ingelheim Investigational Site
state: California
city: Fair Oaks
country: United States
facility: 511.75.01042 Boehringer Ingelheim Investigational Site
state: California
city: Irvine
country: United States
facility: 511.75.01022 Boehringer Ingelheim Investigational Site
state: California
city: La Jolla
country: United States
facility: 511.75.01005 Boehringer Ingelheim Investigational Site
state: California
city: Sacremento
country: United States
facility: 511.75.01053 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.75.01045 Boehringer Ingelheim Investigational Site
state: California
city: Aurora
country: United States
facility: 511.75.01065 Boehringer Ingelheim Investigational Site
state: Colorado
city: Englewood
country: United States
facility: 511.75.01003 Boehringer Ingelheim Investigational Site
state: Colorado
city: Washington
country: United States
facility: 511.75.01030 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Coral Gables
country: United States
facility: 511.75.01066 Boehringer Ingelheim Investigational Site
state: Florida
city: Fort Meyers
country: United States
facility: 511.75.01040 Boehringer Ingelheim Investigational Site
state: Florida
city: Gainesville
country: United States
facility: 511.75.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: Hollywood
country: United States
facility: 511.75.01062 Boehringer Ingelheim Investigational Site
state: Florida
city: Ocala
country: United States
facility: 511.75.01032 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 511.75.01047 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Bay
country: United States
facility: 511.75.01073 Boehringer Ingelheim Investigational Site
state: Florida
city: Sarasota
country: United States
facility: 511.75.01035 Boehringer Ingelheim Investigational Site
state: Florida
city: South Miami
country: United States
facility: 511.75.01010 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 511.75.01041 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.75.01033 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.75.01002 Boehringer Ingelheim Investigational Site
state: Florida
city: Sandy Springs
country: United States
facility: 511.75.01006 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 511.75.01023 Boehringer Ingelheim Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: 511.75.01031 Boehringer Ingelheim Investigational Site
state: Indiana
city: Lafayette
country: United States
facility: 511.75.01050 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Bingham Farms
country: United States
facility: 511.75.01043 Boehringer Ingelheim Investigational Site
state: Michigan
city: Chaska
country: United States
facility: 511.75.01025 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: 511.75.01024 Boehringer Ingelheim Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: 511.75.01009 Boehringer Ingelheim Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: 511.75.01060 Boehringer Ingelheim Investigational Site
state: Nevada
city: New Brunswick
country: United States
facility: 511.75.01004 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Chapel Hill
country: United States
facility: 511.75.01037 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 511.75.01054 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Beachwood
country: United States
facility: 511.75.01069 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 511.75.01012 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: 511.75.01071 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 511.75.01038 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 511.75.01048 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.75.01061 Boehringer Ingelheim Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: 511.75.01020 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 511.75.01052 Boehringer Ingelheim Investigational Site
state: Oregon
city: Medfod
country: United States
facility: 511.75.01059 Boehringer Ingelheim Investigational Site
state: Oregon
city: Portland
country: United States
facility: 511.75.01021 Boehringer Ingelheim Investigational Site
state: Oregon
city: Jenkintown
country: United States
facility: 511.75.01018 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: 511.75.01067 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 511.75.01070 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Knoxville
country: United States
facility: 511.75.01064 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.75.01049 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Austin
country: United States
facility: 511.75.01013 Boehringer Ingelheim Investigational Site
state: Texas
city: Dallas
country: United States
facility: 511.75.01027 Boehringer Ingelheim Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: 511.75.01044 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.75.01011 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.75.01055 Boehringer Ingelheim Investigational Site
state: Texas
city: Waco
country: United States
facility: 511.75.01068 Boehringer Ingelheim Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: 511.75.01007 Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: 511.75.01057 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.75.01046 Boehringer Ingelheim Investigational Site
state: Virginia
city: Seattle
country: United States
facility: 511.75.01019 Boehringer Ingelheim Investigational Site
state: Washington
city: Middleton
country: United States
facility: 511.75.01036 Boehringer Ingelheim Investigational Site
state: Wisconsin
city: Coquitlam
country: Canada
facility: 511.75.02008 Boehringer Ingelheim Investigational Site
state: British Columbia
city: North Vancouver
country: Canada
facility: 511.75.02002 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Woodstock
country: Canada
facility: 511.75.02004 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Mount Pearl
country: Canada
facility: 511.75.02005 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: 511.75.02010 Boehringer Ingelheim Investigational Site
state: Ontario
city: London
country: Canada
facility: 511.75.02011 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 511.75.02001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 511.75.02007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: 511.75.02009 Boehringer Ingelheim Investigational Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: 511.75.02013 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 511.75.02003 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: 511.75.02012 Boehringer Ingelheim Investigational Site
city: Quebec
country: Canada
facility: 511.75.02014 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Thorp J, Simon J, Dattani D, Taylor L, Kimura T, Garcia M Jr, Lesko L, Pyke R; DAISY trial investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study. J Sex Med. 2012 Mar;9(3):793-804. doi: 10.1111/j.1743-6109.2011.02595.x. Epub 2012 Jan 12.