24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder

NCT00360529 | Completed Phase 3 Results DMC

• 2 other identifiers: 511.71VIOLET
• Study Type: interventional
• Target: 880
• Locations: 2 countries
• Sites: 54

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.

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (2)

• Satisfying Sexual Event Monthly Change From Baseline at Final Visit

  Change from baseline in the frequency of sexual satisfying events, as measured via e-Diary, standardized to a 28-day period. Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24.

  Baseline, Week 24

• Sexual Desire Monthly Change on Electronic Diary From Baseline at Final Visit

  Change from baseline in eDiary Sexual Desire Monthly Total Score standardized to a 28-day period. Change from baseline calculated as the difference between the 4 week baseline period and Week 21 to Week 24. Patients recorded information daily throughout trial. Every time the eDiary was completed, a desire question was asked. If a patient did not complete the diary on a given day, the patient was not asked to enter desire information for more than a 24-hour retrospective period. The desire item read "Indicate your most intense level of sexual desire in the last 24 hours/since your last visit." Potential responses included "no," "low," "moderate," or "strong", scored 0-3 (0 indicating no desire and 3 indicating the highest level of desire): 0 = No desire 1. = Low desire 2. = Moderate desire 3. = Strong desire Total score ranged from 0-84, with higher scores reflecting stronger desire). Monthly desire score was calculated as 28 x (sum of daily desire scores/number of responses).

  Baseline, Week 24

Secondary Outcomes (5)

• Female Sexual Distress Scale - Revised (FSDS-R) Total Score Change From Baseline at Final Visit

  Baseline, Week 24

• Female Sexual Distress Scale - Revised (FSDS-R) Question 13 Score Change From Baseline at Final Visit

  Baseline, Week 24

• Female Sexual Functioning Index (FSFI) Desire Domain Score Change From Baseline at Final Visit

  Baseline, Week 24

• Female Sexual Functioning Index (FSFI) Total Score Change From Baseline at Final Visit

  Baseline, Week 24

• Patient Benefit Evaluation

  Week 24

Study Arms (3)

fibanserin

EXPERIMENTAL

flibanserin 50 mg q.h.s.

Drug: flibanserin

flibanserin

EXPERIMENTAL

flibanserin 100 mg q.h.s.

Drug: flibanserin

placebo

PLACEBO COMPARATOR

placebo q.h.s.

Drug: flibanserin

Interventions

flibanserin DRUG

flibanserin placebo versus 50 mg qhs versus 100 mg qhs

Also known as: flibanserin 50 mg, flibanserin 100mg, placebo

fibanserin; flibanserin; placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are 18 years of age and older.
• Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
• Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
• Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
• Patients must be willing and able to use an electronic diary (eDiary) on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
• At the Baseline Visit, patients must have complied with eDiary use adequately.
• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
• 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.
• Patients with a history of drug dependence or abuse within the past one year.
• Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
• 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.
• 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.
• Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
• Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
• Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
• Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
• Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
• 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.
• Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
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Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (54)

511.71.01034 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.71.01042 Boehringer Ingelheim Investigational Site

South Birmingham, Alabama, United States

Location

511.71.01016 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

511.71.01041 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Location

511.71.01011 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.71.01027 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

511.71.01035 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.71.01010 Boehringer Ingelheim Investigational Site

Groton, Connecticut, United States

Location

511.71.01021 Boehringer Ingelheim Investigational Site

New Britain, Connecticut, United States

Location

511.71.01037 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

511.71.01001 Boehringer Ingelheim Investigational Site

Boynton Beach, Florida, United States

Location

511.71.01032 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

511.71.01014 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

511.71.01025 Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Location

511.71.01006 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Location

511.71.01015 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.71.01038 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

511.71.01036 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.71.01029 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Location

511.71.01028 Boehringer Ingelheim Investigational Site

Renton, Indiana, United States

Location

511.71.01024 Boehringer Ingelheim Investigational Site

New Orlean, Louisiana, United States

Location

511.71.01040 Boehringer Ingelheim Investigational Site

Towson, Maryland, United States

Location

511.71.01045 Boehringer Ingelheim Investigational Site

Brighton, Massachusetts, United States

Location

511.71.01005 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

511.71.01030 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

511.71.01007 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Location

511.71.01012 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

511.71.01023 Boehringer Ingelheim Investigational Site

New Bern, North Carolina, United States

Location

511.71.01002 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.71.01044 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.71.01026 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

511.71.01039 Boehringer Ingelheim Investigational Site

Edmond, Oklahoma, United States

Location

511.71.01003 Boehringer Ingelheim Investigational Site

Danville, Pennsylvania, United States

Location

511.71.01033 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

511.71.01031 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

511.71.01022 Boehringer Ingelheim Investigational Site

Mt. Pleasant, South Carolina, United States

Location

511.71.01020 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Location

511.71.01017 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.71.01018 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.71.01008 Boehringer Ingelheim Investigational Site

Huntington, West Virginia, United States

Location

511.71.02002 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

511.71.02006 Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, Canada

Location

511.71.02011 Boehringer Ingelheim Investigational Site

Surrey, British Columbia, Canada

Location

511.71.02007 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

511.71.02008 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

511.71.02012 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

511.71.02010 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

511.71.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

511.71.02004 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

Location

511.71.02013 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

511.71.02009 Boehringer Ingelheim Investigational Site

Oshawa, Ontario, Canada

Location

511.71.02003 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

511.71.02005 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

511.71.02014 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

Related Publications (1)

• Derogatis LR, Komer L, Katz M, Moreau M, Kimura T, Garcia M Jr, Wunderlich G, Pyke R; VIOLET Trial Investigators. Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study. J Sex Med. 2012 Apr;9(4):1074-85. doi: 10.1111/j.1743-6109.2011.02626.x. Epub 2012 Jan 16.

  PMID: 22248038 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Sprout Pharmaceuticals
• Organization: Sprout Pharmaceuticals

clinicaltrials@sproutpharma.com

1-919-882-0850

Study Officials

• Sprout Pharmaceuticals

  Sprout Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 4, 2006
• Study Start: July 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 27, 2016
• Results First Posted: June 27, 2016

Record last verified: 2016-06

Locations

US (40); CA (14)