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

Sexual Dysfunctions, Psychological Clinical Trial

Official title:

Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01103362
• Other study ID #: 511.133
• Status: Terminated
• Phase: Phase 3
• First received: April 13, 2010
• Last updated: April 11, 2014
• Start date: April 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: Sprout Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaGermany: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 596
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. 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.

2. 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.

3. 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.

4. In the investigator's opinion, patients must be willing to adhere to trial requirements as well as to be able to perform them.

5. 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.

Exclusion criteria:

1. 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.

2. 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.

3. 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.

4. Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.

5. Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.

6. 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.

7. 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).

8. Patients with clinically relevant conditions which might interfere with their ability to participate in the trial.

9. Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunctions, Psychological

Intervention

Drug:
• flibanserin
all patients will receive open-label flibanserin 100mg

Locations

Country	Name	City	State
Canada	511.133.02006 Boehringer Ingelheim Investigational Site	Burlington	Ontario
Canada	511.133.02004 Boehringer Ingelheim Investigational Site	Calgary	Alberta
Canada	511.133.02005 Boehringer Ingelheim Investigational Site	Ottawa	Ontario
Canada	511.133.02002 Boehringer Ingelheim Investigational Site	Quebec
Canada	511.133.02003 Boehringer Ingelheim Investigational Site	Saskatoon	Saskatchewan
Canada	511.133.02016 Boehringer Ingelheim Investigational Site	Toronto	Ontario
Canada	511.133.02014 Boehringer Ingelheim Investigational Site	Victoria	British Columbia
United States	511.133.01009 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.133.01023 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	511.133.01013 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	511.133.01014 Boehringer Ingelheim Investigational Site	Billings	Montana
United States	511.133.01031 Boehringer Ingelheim Investigational Site	Bingham Farms	Michigan
United States	511.133.01074 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	511.133.01141 Boehringer Ingelheim Investigational Site	Birmingham	Alabama
United States	511.133.01003 Boehringer Ingelheim Investigational Site	Boynton Beach	Florida
United States	511.133.01135 Boehringer Ingelheim Investigational Site	Cary	North Carolina
United States	511.133.01084 Boehringer Ingelheim Investigational Site	Chattanooga	Tennessee
United States	511.133.01044 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	511.133.01033 Boehringer Ingelheim Investigational Site	Cincinnati	Ohio
United States	511.133.01056 Boehringer Ingelheim Investigational Site	Clearwater	Florida
United States	511.133.01004 Boehringer Ingelheim Investigational Site	Cleveland	Ohio
United States	511.133.01050 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.133.01059 Boehringer Ingelheim Investigational Site	Columbus	Ohio
United States	511.133.01132 Boehringer Ingelheim Investigational Site	Coral Gables	Florida
United States	511.133.01018 Boehringer Ingelheim Investigational Site	Corpus Christi	Texas
United States	511.133.01058 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	511.133.01065 Boehringer Ingelheim Investigational Site	Daytona Beach	Florida
United States	511.133.01071 Boehringer Ingelheim Investigational Site	Denver	Colorado
United States	511.133.01072 Boehringer Ingelheim Investigational Site	Edmond	Oklahoma
United States	511.133.01030 Boehringer Ingelheim Investigational Site	Encinitas	California
United States	511.133.01017 Boehringer Ingelheim Investigational Site	Endwell	New York
United States	511.133.01105 Boehringer Ingelheim Investigational Site	Englewood	Ohio
United States	511.133.01007 Boehringer Ingelheim Investigational Site	Eugene	Oregon
United States	511.133.01028 Boehringer Ingelheim Investigational Site	Fair Oaks	California
United States	511.133.01119 Boehringer Ingelheim Investigational Site	Fargo	North Dakota
United States	511.133.01053 Boehringer Ingelheim Investigational Site	Farmington	Connecticut
United States	511.133.01015 Boehringer Ingelheim Investigational Site	Groton	Connecticut
United States	511.133.01032 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	511.133.01046 Boehringer Ingelheim Investigational Site	Huntsville	Alabama
United States	511.133.01034 Boehringer Ingelheim Investigational Site	Indianapolis	Indiana
United States	511.133.01037 Boehringer Ingelheim Investigational Site	Irvine	California
United States	511.133.01011 Boehringer Ingelheim Investigational Site	Katy	Texas
United States	511.133.01063 Boehringer Ingelheim Investigational Site	Knoxville	Tennessee
United States	511.133.01136 Boehringer Ingelheim Investigational Site	La Mesa	California
United States	511.133.01067 Boehringer Ingelheim Investigational Site	Lafayette	Louisiana
United States	511.133.01057 Boehringer Ingelheim Investigational Site	Las Vegas	Nevada
United States	511.133.01082 Boehringer Ingelheim Investigational Site	Marietta	Georgia
United States	511.133.01020 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	511.133.01024 Boehringer Ingelheim Investigational Site	Miami	Florida
United States	511.133.01042 Boehringer Ingelheim Investigational Site	Mobile	Alabama
United States	511.133.01039 Boehringer Ingelheim Investigational Site	Moorestown	New Jersey
United States	511.133.01068 Boehringer Ingelheim Investigational Site	Mt Pleasant	South Carolina
United States	511.133.01010 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	511.133.01036 Boehringer Ingelheim Investigational Site	Nashville	Tennessee
United States	511.133.01047 Boehringer Ingelheim Investigational Site	New Bern	North Carolina
United States	511.133.01139 Boehringer Ingelheim Investigational Site	New London	Connecticut
United States	511.133.01064 Boehringer Ingelheim Investigational Site	Newark	Delaware
United States	511.133.01128 Boehringer Ingelheim Investigational Site	Newport Beach	California
United States	511.133.01040 Boehringer Ingelheim Investigational Site	Norfolk	Virginia
United States	511.133.01115 Boehringer Ingelheim Investigational Site	Oceanside	California
United States	511.133.01060 Boehringer Ingelheim Investigational Site	Omaha	Nebraska
United States	511.133.01043 Boehringer Ingelheim Investigational Site	Orlando	Florida
United States	511.133.01070 Boehringer Ingelheim Investigational Site	Palm Harbor	Florida
United States	511.133.01025 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	511.133.01073 Boehringer Ingelheim Investigational Site	Phoenix	Arizona
United States	511.133.01055 Boehringer Ingelheim Investigational Site	Pittsburgh	Pennsylvania
United States	511.133.01054 Boehringer Ingelheim Investigational Site	Renton	Washington
United States	511.133.01029 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.133.01075 Boehringer Ingelheim Investigational Site	Richmond	Virginia
United States	511.133.01022 Boehringer Ingelheim Investigational Site	Sacremento	California
United States	511.133.01005 Boehringer Ingelheim Investigational Site	Salt Lake City	Utah
United States	511.133.01012 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.133.01026 Boehringer Ingelheim Investigational Site	San Antonio	Texas
United States	511.133.01035 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.133.01052 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.133.01099 Boehringer Ingelheim Investigational Site	San Diego	California
United States	511.133.01069 Boehringer Ingelheim Investigational Site	Sandy	Utah
United States	511.133.01008 Boehringer Ingelheim Investigational Site	Sandy Springs	Georgia
United States	511.133.01045 Boehringer Ingelheim Investigational Site	Spokane	Washington
United States	511.133.01006 Boehringer Ingelheim Investigational Site	St. Louis	Missouri
United States	511.133.01019 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida
United States	511.133.01038 Boehringer Ingelheim Investigational Site	Tacoma	Washington
United States	511.133.01061 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.133.01066 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	511.133.01016 Boehringer Ingelheim Investigational Site	Tarzana	California
United States	511.133.01127 Boehringer Ingelheim Investigational Site	Tuscon	Arizona
United States	511.133.01049 Boehringer Ingelheim Investigational Site	Virgnia Beach	Virginia
United States	511.133.01021 Boehringer Ingelheim Investigational Site	Vista	California
United States	511.133.01062 Boehringer Ingelheim Investigational Site	Washington	District of Columbia
United States	511.133.01001 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	511.133.01002 Boehringer Ingelheim Investigational Site	West Palm Beach	Florida
United States	511.133.01051 Boehringer Ingelheim Investigational Site	Westlake Village	California
United States	511.133.01100 Boehringer Ingelheim Investigational Site	Wichita	Kansas
United States	511.133.01138 Boehringer Ingelheim Investigational Site	Winston Salem	North Carolina
United States	511.133.01027 Boehringer Ingelheim Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sprout Pharmaceuticals, Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Frequency of Adverse Events		A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD	Yes