Clinical trial NCT01103362: A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Official title: Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sexual Dysfunctions, Psychological
Lead sponsor: Sprout Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-04-14
Enrollment: 596
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The Frequency of Adverse Events
timeFrame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 511.133.01074 Boehringer Ingelheim Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: 511.133.01141 Boehringer Ingelheim Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: 511.133.01046 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 511.133.01042 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 511.133.01025 Boehringer Ingelheim Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: 511.133.01073 Boehringer Ingelheim Investigational Site
state: Arizona
city: Tuscon
country: United States
facility: 511.133.01127 Boehringer Ingelheim Investigational Site
state: Arizona
city: Encinitas
country: United States
facility: 511.133.01030 Boehringer Ingelheim Investigational Site
state: California
city: Fair Oaks
country: United States
facility: 511.133.01028 Boehringer Ingelheim Investigational Site
state: California
city: Irvine
country: United States
facility: 511.133.01037 Boehringer Ingelheim Investigational Site
state: California
city: La Mesa
country: United States
facility: 511.133.01136 Boehringer Ingelheim Investigational Site
state: California
city: Newport Beach
country: United States
facility: 511.133.01128 Boehringer Ingelheim Investigational Site
state: California
city: Oceanside
country: United States
facility: 511.133.01115 Boehringer Ingelheim Investigational Site
state: California
city: Sacremento
country: United States
facility: 511.133.01022 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.133.01035 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.133.01052 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 511.133.01099 Boehringer Ingelheim Investigational Site
state: California
city: Tarzana
country: United States
facility: 511.133.01016 Boehringer Ingelheim Investigational Site
state: California
city: Vista
country: United States
facility: 511.133.01021 Boehringer Ingelheim Investigational Site
state: California
city: Westlake Village
country: United States
facility: 511.133.01051 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 511.133.01071 Boehringer Ingelheim Investigational Site
state: Colorado
city: Farmington
country: United States
facility: 511.133.01053 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Groton
country: United States
facility: 511.133.01015 Boehringer Ingelheim Investigational Site
state: Connecticut
city: New London
country: United States
facility: 511.133.01139 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Newark
country: United States
facility: 511.133.01064 Boehringer Ingelheim Investigational Site
state: Delaware
city: Washington
country: United States
facility: 511.133.01062 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Boynton Beach
country: United States
facility: 511.133.01003 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 511.133.01056 Boehringer Ingelheim Investigational Site
state: Florida
city: Coral Gables
country: United States
facility: 511.133.01132 Boehringer Ingelheim Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: 511.133.01065 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.133.01020 Boehringer Ingelheim Investigational Site
state: Florida
city: Miami
country: United States
facility: 511.133.01024 Boehringer Ingelheim Investigational Site
state: Florida
city: Orlando
country: United States
facility: 511.133.01043 Boehringer Ingelheim Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: 511.133.01070 Boehringer Ingelheim Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: 511.133.01019 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.133.01061 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 511.133.01066 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.133.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: 511.133.01002 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 511.133.01009 Boehringer Ingelheim Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: 511.133.01023 Boehringer Ingelheim Investigational Site
state: Georgia
city: Marietta
country: United States
facility: 511.133.01082 Boehringer Ingelheim Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: 511.133.01008 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 511.133.01044 Boehringer Ingelheim Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: 511.133.01034 Boehringer Ingelheim Investigational Site
state: Indiana
city: Wichita
country: United States
facility: 511.133.01100 Boehringer Ingelheim Investigational Site
state: Kansas
city: Lafayette
country: United States
facility: 511.133.01067 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: 511.133.01013 Boehringer Ingelheim Investigational Site
state: Maryland
city: Bingham Farms
country: United States
facility: 511.133.01031 Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: 511.133.01006 Boehringer Ingelheim Investigational Site
state: Missouri
city: Billings
country: United States
facility: 511.133.01014 Boehringer Ingelheim Investigational Site
state: Montana
city: Omaha
country: United States
facility: 511.133.01060 Boehringer Ingelheim Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: 511.133.01057 Boehringer Ingelheim Investigational Site
state: Nevada
city: Moorestown
country: United States
facility: 511.133.01039 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Endwell
country: United States
facility: 511.133.01017 Boehringer Ingelheim Investigational Site
state: New York
city: Cary
country: United States
facility: 511.133.01135 Boehringer Ingelheim Investigational Site
state: North Carolina
city: New Bern
country: United States
facility: 511.133.01047 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: 511.133.01138 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 511.133.01027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: 511.133.01119 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: 511.133.01033 Boehringer Ingelheim Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: 511.133.01004 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.133.01050 Boehringer Ingelheim Investigational Site
state: Ohio
city: Columbus
country: United States
facility: 511.133.01059 Boehringer Ingelheim Investigational Site
state: Ohio
city: Dayton
country: United States
facility: 511.133.01058 Boehringer Ingelheim Investigational Site
state: Ohio
city: Englewood
country: United States
facility: 511.133.01105 Boehringer Ingelheim Investigational Site
state: Ohio
city: Edmond
country: United States
facility: 511.133.01072 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: 511.133.01007 Boehringer Ingelheim Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: 511.133.01055 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Mt Pleasant
country: United States
facility: 511.133.01068 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Chattanooga
country: United States
facility: 511.133.01084 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: 511.133.01063 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.133.01010 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 511.133.01036 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Corpus Christi
country: United States
facility: 511.133.01018 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 511.133.01032 Boehringer Ingelheim Investigational Site
state: Texas
city: Katy
country: United States
facility: 511.133.01011 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.133.01012 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 511.133.01026 Boehringer Ingelheim Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: 511.133.01005 Boehringer Ingelheim Investigational Site
state: Utah
city: Sandy
country: United States
facility: 511.133.01069 Boehringer Ingelheim Investigational Site
state: Utah
city: Norfolk
country: United States
facility: 511.133.01040 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.133.01029 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 511.133.01075 Boehringer Ingelheim Investigational Site
state: Virginia
city: Virgnia Beach
country: United States
facility: 511.133.01049 Boehringer Ingelheim Investigational Site
state: Virginia
city: Renton
country: United States
facility: 511.133.01054 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 511.133.01045 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 511.133.01038 Boehringer Ingelheim Investigational Site
state: Washington
city: Calgary
country: Canada
facility: 511.133.02004 Boehringer Ingelheim Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: 511.133.02014 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Burlington
country: Canada
facility: 511.133.02006 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 511.133.02005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 511.133.02016 Boehringer Ingelheim Investigational Site
state: Ontario
city: Saskatoon
country: Canada
facility: 511.133.02003 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: 511.133.02002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Sprout Pharmaceuticals
name: Sprout Pharmaceuticals
role: STUDY_CHAIR
References:
citation: 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.