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

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ClinicalTrials.gov Identifier: NCT01103362
Recruitment Status : Terminated (administrative reasons)
First Posted : April 14, 2010
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Sprout Pharmaceuticals, Inc

Tracking Information
First Submitted Date  ICMJE April 13, 2010
First Posted Date  ICMJE April 14, 2010
Results First Submitted Date  ICMJE April 11, 2014
Results First Posted Date  ICMJE May 12, 2014
Last Update Posted Date May 12, 2014
Study Start Date  ICMJE April 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
The Frequency of Adverse Events [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
The frequency of adverse events. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2010)
  • 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 ]
  • Clinically significant changes to labs. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
  • 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 ]
  • Questionnaires related to sexual health. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
  • Questionnaires related to depression. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
  • Questionnaires related to suicidal thoughts. [ Time Frame: A 28-week, open-label, safety, extension trial of flibanserin in premenopausal and postmenopausal women with HSDD ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
Official Title  ICMJE Open-label Extension Trial for Pre- and Postmenopausal Women With HSDD
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sexual Dysfunctions, Psychological
Intervention  ICMJE Drug: flibanserin
all patients will receive open-label flibanserin 100mg
Study Arms  ICMJE Experimental: flibanserin 100mg
flibanserin 100mg po qd
Intervention: Drug: flibanserin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 15, 2010)
596
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2010)
1140
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103362
Other Study ID Numbers  ICMJE 511.133
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sprout Pharmaceuticals, Inc
Study Sponsor  ICMJE Sprout Pharmaceuticals, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sprout Pharmaceuticals Sprout Pharmaceuticals
PRS Account Sprout Pharmaceuticals, Inc
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP