A Twenty-eight Week Safety, Extension Study of Flibanserin to Treat Premenopausal and Postmenopausal Women With Hypoactive Sexual Desire Disorder
This study has been terminated.
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc
First received: April 13, 2010
Last updated: March 14, 2012
Last verified: March 2012
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).
Sexual Dysfunctions, Psychological
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
Primary Outcome Measures:
- The frequency of adverse events. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Clinically significant changes to pelvic exam. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
- Clinically significant changes to labs. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
- Clinically significant changes to overall patient status. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
- Questionnaires related to sexual health. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
- Questionnaires related to depression. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
- Questionnaires related to suicidal thoughts. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
Experimental: flibanserin 100mg
flibanserin 100mg po qd
all patients will receive open-label flibanserin 100mg
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Women with a primary diagnosis of HSDD who have completed a prior trial of flibanserin (Protocol 511.130, 511.147. or 511.156). Such completion requires adequate compliance, in the investigator's judgment, with trial medication and the trial visit schedule including any post-treatment visit(s) 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 their parent trial.
- The premenopausal patient must have used a medically acceptable method of contraception (i.e., double barrier method [i.e., diaphragm or condom and spermicide], hormonal contraceptive [subcutaneous, injectable, intra-vaginal, or oral]), intrauterine device, tubal sterilization, or partner's surgical sterilization] for at least two months before baseline (Visit 2) and continue to use that medically acceptable method of contraception during the trial. However, if the use of a contraceptive is judged to be a contributing factor to the patient's HSDD, the patient should be excluded from the trial.
- The postmenopausal patient 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 reliable, honest, compliant, and agree to co operate with all trial evaluations 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 their sexual functioning with the investigative staff.
- Patients with a 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 indicates in the patient's source documents for this trial that a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may still be entered into the trial. NOTE: If a patient selects a 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. NOTE: Patients with exclusionary but curable conditions at the Screen Visit (i.e., lower urinary tract infection, vaginitis), may be treated during the screening period. The patient will be eligible for the trial only if the condition resolves prior to the Baseline Visit.
- At the Screen Visit, patients with a 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, in the investigator's opinion, by abdominal or vaginal hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.
- Premenopausal 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 that were excluded in their prior safety and efficacy trial of flibanserin (within the same time frame after the Screen Visit), causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, mood stabilizers, anticonvulsants, anticoagulants).
- In the opinion of the Investigator, patients experiencing major life stress (including parenting pressure, eldercare, loss of income, death of a family member, major illness, etc.) or relationship discord that could interfere with sexual activity, except distress about HSDD.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103362
Sprout Pharmaceuticals, Inc
No publications provided
||Sprout Pharmaceuticals, Inc
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2010
||March 14, 2012
||Canada: Health Canada
United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders