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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360555
Recruitment Status : Completed
First Posted : August 4, 2006
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc

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.

Condition or disease Intervention/treatment Phase
Sexual Dysfunctions, Psychological Drug: flibanserin Drug: flibanserin 50mg Drug: flibanserin 100mg Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

Arm Intervention/treatment
Experimental: flibanserin
flibanserin 25 mg b.i.d
Drug: flibanserin 50mg
flibanserin 50mg qhs/b.i.d.

Experimental: flibanserin 50mg
flibanserin 50mg qhs/b.i.d
Drug: flibanserin 100mg
flibanserin 50 mg b.i.d/100mg qhs

Experimental: flibanserin 100mg
flibanserin 50mg b.i.d./100mg qhs
Drug: placebo
placebo comparator

Placebo Comparator: placebo
placebo comparator
Drug: flibanserin
flibanserin 25 mg b.i.d

Primary Outcome Measures :
  1. Change From Baseline in the Frequency of Satisfying Sexual Events (SSE) as Recorded in the eDiary. [ Time Frame: baseline to 28 weeks ]

    For endpoints collected on the eDiary, responses are accumulated on a monthly basis using the following algorithms.

    For satisfying sexual events:

    Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered)

  2. Change From Baseline in the Monthly Sum of Responses Recorded in the eDiary to the Daily Desire Question. [ Time Frame: baseline to 24 weeks ]

    Change from baseline in the electronic diary (eDiary) Sexual Desire Monthly Total Score standardized to a 28-day period (score range 0-84). Change from baseline is calculated as the difference between the four week baseline period and Week 21 to Week 24. Patients were asked to record information daily in the eDiary throughout the 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" and was scored 0-3, with 0 indicating no desire and 3 indicating the highest level of desire:

    0 = No desire

    1. = Low desire
    2. = Moderate desire
    3. = Strong desire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00360555

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Sponsors and Collaborators
Sprout Pharmaceuticals, Inc
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sprout Pharmaceuticals, Inc Identifier: NCT00360555    
Other Study ID Numbers: 511.75
First Posted: August 4, 2006    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Sexual Dysfunctions, Psychological
Mental Disorders