Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America

• ClinicalTrials.gov Identifier: NCT01057901
• Recruitment Status: Terminated
• First Posted: January 28, 2010
• Results First Posted: June 17, 2014
• Last Update Posted: June 17, 2014
• Sponsor: Sprout Pharmaceuticals, Inc
• Information provided by (Responsible Party): Sprout Pharmaceuticals, Inc

Tracking Information

• First Submitted Date: January 25, 2010
• First Posted Date: January 28, 2010
• Results First Submitted Date: April 14, 2014
• Results First Posted Date: June 17, 2014
• Last Update Posted Date: June 17, 2014
• Study Start Date: January 2010
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 16, 2014)

• Change From Baseline in the Number of Satisfying Sexual Events [ Time Frame: baseline to 24 weeks ]
  The change from baseline in the number of SSE's as measured by the eDiary. The calculation of Satisfying Sexual Event (SSEs) will be standardized to a 28-day period according to the below formula: Total monthly events = 28 x (sum of the number of events) / (sum of number of days entered). "Satisfying" means gratifying, fulfilling, satisfactory, and/or successful for the patient. The partner's satisfaction is not the subject of this question.
• Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain [ Time Frame: baseline to 24 weeks ]
  The Female Sexual Function Index (FSFI) is a brief, multidimensional, self-administered questionnaire for assessing key domains of sexual function in women. The scale consists of 19 items that assess sexual function over the past four weeks and yields scores in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The two items in the desire domain are scored from 1 to 5 (1 is lowest level of desire and 5 is the highest level of desire). The raw scores of the two items are added together and then multiplied by the domain factor of 0.6. Thus, the score of the desire domain ranges from 1.2 (lowest level of desire) to 6.0 (highest level of desire). For the entire instrument, each of the six domains contributes a maximum of 6 points to the total. Scores on the full scale range from a minimum of 2 to a maximum of 36.

• Original Primary Outcome Measures (submitted: January 27, 2010): Change from baseline in the number of satisfying sexual events Change from baseline in the score on the Female Sexual Function Index (FSFI) desire domain [ Time Frame: 24 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: January 27, 2010): Change from baseline on Question 13 of the Female Sexual Distress Scale Revised (FSDS R) Change from baseline on FSDS R total score Change from baseline on FSFI total score Score on Patient Global Impression of Improvement [ Time Frame: 24 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
• Official Title: 24 - Week Flibanserin 100mg for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in Noth America
• Brief Summary: The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Sexual Dysfunctions, Psychological

Intervention

• Drug: Flibanserin
  Flibanserin 100mg administered at bedtime for 24 weeks
• Drug: Placebo
  This is the matched placebo which will be administered two tablets daily at bedtime.

Study Arms

• Experimental: Flibanserin 100 mg
  Flibanserin 100 mg administered at bedtime
  Intervention: Drug: Flibanserin
• Placebo Comparator: Placebo
  This is the matched placebo which will be administered two tablets daily at bedtime.
  Intervention: Drug: Placebo

• Publications *: Portman DJ, Brown L, Yuan J, Kissling R, Kingsberg SA. Flibanserin in Postmenopausal Women With Hypoactive Sexual Desire Disorder: Results of the PLUMERIA Study. J Sex Med. 2017 Jun;14(6):834-842. doi: 10.1016/j.jsxm.2017.03.258.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 15, 2010): 748
• Original Estimated Enrollment (submitted: January 27, 2010): 900
• Actual Study Completion Date: January 2011
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion criteria:

• Naturally postmenopausal women of any age with at least one ovary
• Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
• Stable, monogamous heterosexual relationship for at least one year
• Willing to discuss sexual issues
• Willing to engage in sexual activity at least once a month
• Normal Pap smear
• Normal mammogram
• Normal uterine lining
• Able to comply with daily use of handheld data entry device

Exclusion criteria:

• Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
• Partner with inadequately treated organic or psychosexual dysfunction
• Sexual function impaired by psychiatric disorder
• Sexual function impaired by gynecological disorder
• Major Depression
• Suicidal behavior or ideation
• Major life stress that could impair sexual function
• Substance abuse

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 35 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT01057901
• Other Study ID Numbers: 511.156
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sprout Pharmaceuticals, Inc
• Original Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
• Current Study Sponsor: Sprout Pharmaceuticals, Inc
• Original Study Sponsor: Boehringer Ingelheim
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Sprout Pharmaceuticals, Inc
• Verification Date: June 2014