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

NCT01057901 | Terminated Phase 3 Results DMC

• 1 other identifier: 511.156
• Study Type: interventional
• Target: 748
• Locations: 2 countries
• Sites: 100

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.

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Number of Satisfying Sexual Events

  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.

  baseline to 24 weeks

• Change From Baseline in the Score on the Female Sexual Function Index (FSFI) Desire Domain

  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.

  baseline to 24 weeks

Study Arms (2)

Flibanserin 100 mg

EXPERIMENTAL

Flibanserin 100 mg administered at bedtime

Drug: Flibanserin

Placebo

PLACEBO COMPARATOR

This is the matched placebo which will be administered two tablets daily at bedtime.

Drug: Placebo

Interventions

Flibanserin DRUG

Flibanserin 100mg administered at bedtime for 24 weeks

Flibanserin 100 mg

Placebo DRUG

This is the matched placebo which will be administered two tablets daily at bedtime.

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (100)

511.156.01059 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

511.156.01084 Boehringer Ingelheim Investigational Site

Tucson, Arizona, United States

Location

511.156.01053 Boehringer Ingelheim Investigational Site

Tuscon, Arizona, United States

Location

511.156.01069 Boehringer Ingelheim Investigational Site

Tuscon, Arizona, United States

Location

511.156.01063 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

511.156.01076 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Location

511.156.01039 Boehringer Ingelheim Investigational Site

Anaheim, California, United States

Location

511.156.01070 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

511.156.01075 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Location

511.156.01087 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

511.156.01064 Boehringer Ingelheim Investigational Site

Newport Beach, California, United States

Location

511.156.01016 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Location

511.156.01007 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.156.01038 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.156.01067 Boehringer Ingelheim Investigational Site

Colorado Springs, Colorado, United States

Location

511.156.01036 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.156.01092 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Location

511.156.01027 Boehringer Ingelheim Investigational Site

New London, Connecticut, United States

Location

511.156.01022 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

511.156.01042 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

511.156.01047 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

511.156.01051 Boehringer Ingelheim Investigational Site

Fort Lauderdale, Florida, United States

Location

511.156.01011 Boehringer Ingelheim Investigational Site

Gainseville, Florida, United States

Location

511.156.01078 Boehringer Ingelheim Investigational Site

Lake Worth, Florida, United States

Location

511.156.01095 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

511.156.01046 Boehringer Ingelheim Investigational Site

Plantation, Florida, United States

Location

511.156.01056 Boehringer Ingelheim Investigational Site

Columbus, Georgia, United States

Location

511.156.01045 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

511.156.01021 Boehringer Ingelheim Investigational Site

Roswell, Georgia, United States

Location

511.156.01081 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Location

511.156.01066 Boehringer Ingelheim Investigational Site

Boise, Idaho, United States

Location

511.156.01025 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.156.01028 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.156.01089 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Location

511.156.01010 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

511.156.01008 Boehringer Ingelheim Investigational Site

Lexington, Kentucky, United States

Location

511.156.01034 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

511.156.01012 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

511.156.01074 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

511.156.01079 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

511.156.01080 Boehringer Ingelheim Investigational Site

Haverhill, Massachusetts, United States

Location

511.156.01006 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

511.156.01086 Boehringer Ingelheim Investigational Site

Paw Paw, Michigan, United States

Location

511.156.01005 Boehringer Ingelheim Investigational Site

Chaska, Minnesota, United States

Location

511.156.01013 Boehringer Ingelheim Investigational Site

Olive Branch, Mississippi, United States

Location

511.156.01088 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

511.156.01001 Boehringer Ingelheim Investigational Site

New Brunswick, New Jersey, United States

Location

511.156.01055 Boehringer Ingelheim Investigational Site

Plainsboro, New Jersey, United States

Location

511.156.01037 Boehringer Ingelheim Investigational Site

Poughkeepsie, New York, United States

Location

511.156.01031 Boehringer Ingelheim Investigational Site

Purchase, New York, United States

Location

511.156.01009 Boehringer Ingelheim Investigational Site

The Bronx, New York, United States

Location

511.156.01024 Boehringer Ingelheim Investigational Site

Cary, North Carolina, United States

Location

511.156.01065 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

511.156.01029 Boehringer Ingelheim Investigational Site

Greensboro, North Carolina, United States

Location

511.156.01002 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

511.156.01040 Boehringer Ingelheim Investigational Site

Statesville, North Carolina, United States

Location

511.156.01026 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

511.156.01093 Boehringer Ingelheim Investigational Site

Bismarck, North Dakota, United States

Location

511.156.01052 Boehringer Ingelheim Investigational Site

Fargo, North Dakota, United States

Location

511.156.01017 Boehringer Ingelheim Investigational Site

Beachwood, Ohio, United States

Location

511.156.01032 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.156.01033 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.156.01068 Boehringer Ingelheim Investigational Site

Englewood, Ohio, United States

Location

511.156.01077 Boehringer Ingelheim Investigational Site

Ashland, Oregon, United States

Location

511.156.01072 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

511.156.01082 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

511.156.01094 Boehringer Ingelheim Investigational Site

West Reading, Pennsylvania, United States

Location

511.156.01083 Boehringer Ingelheim Investigational Site

Warwick, Rhode Island, United States

Location

511.156.01048 Boehringer Ingelheim Investigational Site

Anderson, South Carolina, United States

Location

511.156.01058 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

511.156.01085 Boehringer Ingelheim Investigational Site

Watertown, South Dakota, United States

Location

511.156.01073 Boehringer Ingelheim Investigational Site

Bristol, Tennessee, United States

Location

511.156.01041 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Location

511.156.01035 Boehringer Ingelheim Investigational Site

Germantown, Tennessee, United States

Location

511.156.01091 Boehringer Ingelheim Investigational Site

Jackson, Tennessee, United States

Location

511.156.01060 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Location

511.156.01003 Boehringer Ingelheim Investigational Site

Austin, Texas, United States

Location

511.156.01054 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

511.156.01050 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

511.156.01014 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

511.156.01049 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.156.01015 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

511.156.01090 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

511.156.01020 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

511.156.02004 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

511.156.02010 Boehringer Ingelheim Investigational Site

Coquitlam, British Columbia, Canada

Location

511.156.02009 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

511.156.02014 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

511.156.02012 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

511.156.02017 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

511.156.02007 Boehringer Ingelheim Investigational Site

Woodstock, New Brunswick, Canada

Location

511.156.02008 Boehringer Ingelheim Investigational Site

Mount Pearl, Newfoundland and Labrador, Canada

Location

511.156.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

511.156.02013 Boehringer Ingelheim Investigational Site

Barrie, Ontario, Canada

Location

511.156.02006 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

Location

511.156.02005 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

511.156.02016 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

511.156.02002 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

511.156.02015 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Location

511.156.02003 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 28583342 DERIVED

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

flibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Krista Barbour, Ph.D.
• Organization: Sprout Pharmaceuticals

kbarbour@sproutpharma.com

9198820850

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: January 25, 2010
• First Posted: January 28, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: June 17, 2014
• Results First Posted: June 17, 2014

Record last verified: 2014-06

Locations

US (84); CA (16)