A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder

NCT01103362 | Terminated Phase 3 Results DMC

• 1 other identifier: 511.133
• Study Type: interventional
• Target: 596
• Locations: 2 countries
• Sites: 95

Brief Summary

To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Conditions

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• The Frequency of Adverse Events

  A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD

Study Arms (1)

flibanserin 100mg

EXPERIMENTAL

flibanserin 100mg po qd

Drug: flibanserin

Interventions

flibanserin DRUG

all patients will receive open-label flibanserin 100mg

flibanserin 100mg

Eligibility Criteria

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

You may qualify if:

• Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial.
• The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial.
• Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea.
• In the investigator's opinion, patients must be willing to adhere to trial requirements 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 sexual functioning with study staff.

You may not qualify if:

• Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.
• At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin \<9.5 grams/dL, leukopenia (\<2.5 x 103/microliter \[µL\]), neutropenia (\<1.5 x 103/µL), lymphopenia (\<0.8 x 103/µL), thrombocytopenia (\<100 x 103/µL) or thrombocytosis (\>500 x 103/µL); or random glucose \> upper limit of normal.
• Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
• Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
• Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.
• Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been pregnant within the month prior to the Screen Visit or who are breast-feeding or have breast-fed within the last six months prior to the Baseline Visit.
• Patients receiving medication excluded in their prior safety and efficacy trial of flibanserin causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants).
• Patients with clinically relevant conditions which might interfere with their ability to participate in the trial.
• Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.

Sponsors & Collaborators

• Sprout Pharmaceuticals, Inc: lead

Study Sites (95)

511.133.01074 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

511.133.01141 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

511.133.01046 Boehringer Ingelheim Investigational Site

Huntsville, Alabama, United States

Location

511.133.01042 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

511.133.01025 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

511.133.01073 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

511.133.01127 Boehringer Ingelheim Investigational Site

Tuscon, Arizona, United States

Location

511.133.01030 Boehringer Ingelheim Investigational Site

Encinitas, California, United States

Location

511.133.01028 Boehringer Ingelheim Investigational Site

Fair Oaks, California, United States

Location

511.133.01037 Boehringer Ingelheim Investigational Site

Irvine, California, United States

Location

511.133.01136 Boehringer Ingelheim Investigational Site

La Mesa, California, United States

Location

511.133.01128 Boehringer Ingelheim Investigational Site

Newport Beach, California, United States

Location

511.133.01115 Boehringer Ingelheim Investigational Site

Oceanside, California, United States

Location

511.133.01022 Boehringer Ingelheim Investigational Site

Sacremento, California, United States

Location

511.133.01035 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.133.01052 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.133.01099 Boehringer Ingelheim Investigational Site

San Diego, California, United States

Location

511.133.01016 Boehringer Ingelheim Investigational Site

Tarzana, California, United States

Location

511.133.01021 Boehringer Ingelheim Investigational Site

Vista, California, United States

Location

511.133.01051 Boehringer Ingelheim Investigational Site

Westlake Village, California, United States

Location

511.133.01071 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

511.133.01053 Boehringer Ingelheim Investigational Site

Farmington, Connecticut, United States

Location

511.133.01015 Boehringer Ingelheim Investigational Site

Groton, Connecticut, United States

Location

511.133.01139 Boehringer Ingelheim Investigational Site

New London, Connecticut, United States

Location

511.133.01064 Boehringer Ingelheim Investigational Site

Newark, Delaware, United States

Location

511.133.01062 Boehringer Ingelheim Investigational Site

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

Location

511.133.01003 Boehringer Ingelheim Investigational Site

Boynton Beach, Florida, United States

Location

511.133.01056 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

511.133.01132 Boehringer Ingelheim Investigational Site

Coral Gables, Florida, United States

Location

511.133.01065 Boehringer Ingelheim Investigational Site

Daytona Beach, Florida, United States

Location

511.133.01020 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

511.133.01024 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Location

511.133.01043 Boehringer Ingelheim Investigational Site

Orlando, Florida, United States

Location

511.133.01070 Boehringer Ingelheim Investigational Site

Palm Harbor, Florida, United States

Location

511.133.01019 Boehringer Ingelheim Investigational Site

St. Petersburg, Florida, United States

Location

511.133.01061 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.133.01066 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

511.133.01001 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

511.133.01002 Boehringer Ingelheim Investigational Site

West Palm Beach, Florida, United States

Location

511.133.01009 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.133.01023 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

511.133.01082 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

511.133.01008 Boehringer Ingelheim Investigational Site

Sandy Springs, Georgia, United States

Location

511.133.01044 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Location

511.133.01034 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

Location

511.133.01100 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

511.133.01067 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

511.133.01013 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

511.133.01031 Boehringer Ingelheim Investigational Site

Bingham Farms, Michigan, United States

Location

511.133.01006 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

511.133.01014 Boehringer Ingelheim Investigational Site

Billings, Montana, United States

Location

511.133.01060 Boehringer Ingelheim Investigational Site

Omaha, Nebraska, United States

Location

511.133.01057 Boehringer Ingelheim Investigational Site

Las Vegas, Nevada, United States

Location

511.133.01039 Boehringer Ingelheim Investigational Site

Moorestown, New Jersey, United States

Location

511.133.01017 Boehringer Ingelheim Investigational Site

Endwell, New York, United States

Location

511.133.01135 Boehringer Ingelheim Investigational Site

Cary, North Carolina, United States

Location

511.133.01047 Boehringer Ingelheim Investigational Site

New Bern, North Carolina, United States

Location

511.133.01027 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

511.133.01138 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

511.133.01119 Boehringer Ingelheim Investigational Site

Fargo, North Dakota, United States

Location

511.133.01033 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

511.133.01004 Boehringer Ingelheim Investigational Site

Cleveland, Ohio, United States

Location

511.133.01050 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

511.133.01059 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

511.133.01058 Boehringer Ingelheim Investigational Site

Dayton, Ohio, United States

Location

511.133.01105 Boehringer Ingelheim Investigational Site

Englewood, Ohio, United States

Location

511.133.01072 Boehringer Ingelheim Investigational Site

Edmond, Oklahoma, United States

Location

511.133.01007 Boehringer Ingelheim Investigational Site

Eugene, Oregon, United States

Location

511.133.01055 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

511.133.01068 Boehringer Ingelheim Investigational Site

Mt. Pleasant, South Carolina, United States

Location

511.133.01084 Boehringer Ingelheim Investigational Site

Chattanooga, Tennessee, United States

Location

511.133.01063 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Location

511.133.01010 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

511.133.01036 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

511.133.01018 Boehringer Ingelheim Investigational Site

Corpus Christi, Texas, United States

Location

511.133.01032 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

511.133.01011 Boehringer Ingelheim Investigational Site

Katy, Texas, United States

Location

511.133.01012 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.133.01026 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

511.133.01005 Boehringer Ingelheim Investigational Site

Salt Lake City, Utah, United States

Location

511.133.01069 Boehringer Ingelheim Investigational Site

Sandy City, Utah, United States

Location

511.133.01040 Boehringer Ingelheim Investigational Site

Norfolk, Virginia, United States

Location

511.133.01029 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

511.133.01075 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

511.133.01049 Boehringer Ingelheim Investigational Site

Virgnia Beach, Virginia, United States

Location

511.133.01054 Boehringer Ingelheim Investigational Site

Renton, Washington, United States

Location

511.133.01045 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

511.133.01038 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

511.133.02004 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

511.133.02014 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

511.133.02006 Boehringer Ingelheim Investigational Site

Burlington, Ontario, Canada

Location

511.133.02005 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

511.133.02016 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

511.133.02002 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

511.133.02003 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• Simon JA, Derogatis L, Portman D, Brown L, Yuan J, Kissling R. Flibanserin for Hypoactive Sexual Desire Disorder: An Open-Label Safety Study. J Sex Med. 2018 Mar;15(3):387-395. doi: 10.1016/j.jsxm.2017.12.016.

  PMID: 29502984 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

• Sprout Pharmaceuticals

  Sprout Pharmaceuticals

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: April 14, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 12, 2014
• Results First Posted: May 12, 2014

Record last verified: 2014-04

Locations

US (88); CA (7)