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Uptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder

NCT ID: NCT00360555

Last Updated: 2016-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1584 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sexual Dysfunctions, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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flibanserin

flibanserin 25 mg b.i.d

Group Type EXPERIMENTAL

flibanserin 50mg

Intervention Type DRUG

flibanserin 50mg qhs/b.i.d.

flibanserin 50mg

flibanserin 50mg qhs/b.i.d

Group Type EXPERIMENTAL

flibanserin 100mg

Intervention Type DRUG

flibanserin 50 mg b.i.d/100mg qhs

flibanserin 100mg

flibanserin 50mg b.i.d./100mg qhs

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

placebo comparator

placebo

placebo comparator

Group Type PLACEBO_COMPARATOR

flibanserin

Intervention Type DRUG

flibanserin 25 mg b.i.d

Interventions

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flibanserin

flibanserin 25 mg b.i.d

Intervention Type DRUG

flibanserin 50mg

flibanserin 50mg qhs/b.i.d.

Intervention Type DRUG

flibanserin 100mg

flibanserin 50 mg b.i.d/100mg qhs

Intervention Type DRUG

placebo

placebo comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sprout Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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511.75.01015 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

511.75.01028 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

511.75.01051 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Site Status

511.75.01063 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

511.75.01017 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

511.75.01014 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Site Status

511.75.01042 Boehringer Ingelheim Investigational Site

Fair Oaks, California, United States

Site Status

511.75.01022 Boehringer Ingelheim Investigational Site

Irvine, California, United States

Site Status

511.75.01005 Boehringer Ingelheim Investigational Site

La Jolla, California, United States

Site Status

511.75.01053 Boehringer Ingelheim Investigational Site

Sacremento, California, United States

Site Status

511.75.01045 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

511.75.01065 Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Site Status

511.75.01003 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

Site Status

511.75.01030 Boehringer Ingelheim Investigational Site

Washington D.C., District of Columbia, United States

Site Status

511.75.01066 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Site Status

511.75.01040 Boehringer Ingelheim Investigational Site

Fort Meyers, Florida, United States

Site Status

511.75.01001 Boehringer Ingelheim Investigational Site

Gainesville, Florida, United States

Site Status

511.75.01062 Boehringer Ingelheim Investigational Site

Hollywood, Florida, United States

Site Status

511.75.01032 Boehringer Ingelheim Investigational Site

Ocala, Florida, United States

Site Status

511.75.01047 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Site Status

511.75.01073 Boehringer Ingelheim Investigational Site

Palm Bay, Florida, United States

Site Status

511.75.01035 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Site Status

511.75.01010 Boehringer Ingelheim Investigational Site

South Miami, Florida, United States

Site Status

511.75.01041 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Site Status

511.75.01033 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

511.75.01002 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Site Status

511.75.01006 Boehringer Ingelheim Investigational Site

Sandy Springs, Georgia, United States

Site Status

511.75.01023 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

511.75.01031 Boehringer Ingelheim Investigational Site

Fort Wayne, Indiana, United States

Site Status

511.75.01050 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Site Status

511.75.01043 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Site Status

511.75.01025 Boehringer Ingelheim Investigational Site

Chaska, Minnesota, United States

Site Status

511.75.01024 Boehringer Ingelheim Investigational Site

Chesterfield, Missouri, United States

Site Status

511.75.01009 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Site Status

511.75.01060 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Site Status

511.75.01004 Boehringer Ingelheim Investigational Site

New Brunswick, New Jersey, United States

Site Status

511.75.01037 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Site Status

511.75.01054 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

511.75.01069 Boehringer Ingelheim Investigational Site

Beachwood, Ohio, United States

Site Status

511.75.01012 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

511.75.01071 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

511.75.01038 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

511.75.01048 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Site Status

511.75.01061 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Site Status

511.75.01020 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Site Status

511.75.01052 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Site Status

511.75.01059 Boehringer Ingelheim Investigational Site

Medfod, Oregon, United States

Site Status

511.75.01021 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Site Status

511.75.01018 Boehringer Ingelheim Investigational Site

Jenkintown, Pennsylvania, United States

Site Status

511.75.01067 Boehringer Ingelheim Investigational Site

Columbia, South Carolina, United States

Site Status

511.75.01070 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

511.75.01064 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Site Status

511.75.01049 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Site Status

511.75.01013 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Site Status

511.75.01027 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

511.75.01044 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Site Status

511.75.01011 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

511.75.01055 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

511.75.01068 Boehringer Ingelheim Investigational Site

Waco, Texas, United States

Site Status

511.75.01007 Boehringer Ingelheim Investigational Site

Charlottesville, Virginia, United States

Site Status

511.75.01057 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Site Status

511.75.01046 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

511.75.01019 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Site Status

511.75.01036 Boehringer Ingelheim Investigational Site

Middleton, Wisconsin, United States

Site Status

511.75.02008 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Site Status

511.75.02002 Boehringer Ingelheim Investigational Site

North Vancouver, British Columbia, Canada

Site Status

511.75.02004 Boehringer Ingelheim Investigational Site

Woodstock, New Brunswick, Canada

Site Status

511.75.02005 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

511.75.02010 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Site Status

511.75.02011 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Site Status

511.75.02001 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

511.75.02007 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

511.75.02012 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

511.75.02014 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

511.75.02009 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

511.75.02013 Boehringer Ingelheim Investigational Site

Trois-Rivières, Quebec, Canada

Site Status

511.75.02003 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 22239862 (View on PubMed)

Other Identifiers

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511.75

Identifier Type: -

Identifier Source: org_study_id

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