Back to resultsFlibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Primary Purpose
Hypoactive Sexual Desire Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sex therapy
flibanserin
Sponsored by
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring hypoactive sexual desire disorder, Addyi, flibanserin, low sexual desire, HSDD
Eligibility Criteria
Inclusion Criteria:
- Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
- Subject is female;
- Subject is ≥18 years old;
- Subject has biologic-based HSDD as her primary sexual complaint;
- Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening;
- Subject scores >18 on FSDS-DAO;
- Subject answers yes to questions 1-4 on the DSDS screener;
- Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
- Subject agrees to comply with the study procedures and visits.
Exclusion Criteria:
- Subject has sexual pain;
- Subject does not have generalized, acquired HSDD;
- Subject has used flibanserin in the last 6 months;
- Subject has history of alcohol or drug abuse;
- Subject uses tobacco in any form;
- Subject is currently using androgen therapy and unwilling to washout;
- Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
- Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
- Subject is taking a CYP3A4 inducer;
- P-glycoprotein substrate;
- Subject has a history of liver impairment;
- Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
- Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Sites / Locations
- San Diego Sexual Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
flibanserin
flibanserin and sex therapy
Arm Description
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug as well as 9 sex therapy visits
Outcomes
Primary Outcome Measures
Desire domain of the Female Sexual Function Index (FSFI)
The primary objective of this study is to determine whether efficacy of flibanserin as determined by changes in the desire domain of the Female Sexual Function Index (FSFI) in women who respond to the study medication is greater when sex therapy is performed concomitant with the use of the medication.
Secondary Outcome Measures
Female Sexual Distress Scale (FSDS-DAO)
One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the Female Sexual Distress Scale (FSDS-DAO) in women who respond to the study medication.
Total score of the Female Sexual Function Index (FSFI)
One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the total FSFI score respectively in women who respond to the study medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02714049
Brief Title
Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Official Title
Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Investor Initiated Grant support stopped when drug was sold.
Study Start Date
January 25, 2017 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Diego Sexual Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Unblinded study of flibanserin for 8 weeks with responders randomized 1:1 to receive study medication alone vs. study medication and sex therapy for 12 additional weeks.
Detailed Description
This is an unblinded study to be conducted at a single research center, San Diego Sexual Medicine. Subjects meeting inclusion and exclusion criteria will receive flibanserin for an 8-week run-in period to differentiate between responders and non-responders. Responders will be determined by a score of 1-3 on the Patient Global Impression of Improvement (PGI-I) at 8 weeks from baseline, and will be randomized 1:1 to receive study medication alone vs. study medication and sex therapy for an additional 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder
Keywords
hypoactive sexual desire disorder, Addyi, flibanserin, low sexual desire, HSDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
flibanserin
Arm Type
Experimental
Arm Description
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug
Arm Title
flibanserin and sex therapy
Arm Type
Experimental
Arm Description
Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug as well as 9 sex therapy visits
Intervention Type
Behavioral
Intervention Name(s)
sex therapy
Other Intervention Name(s)
psychotherapy
Intervention Description
60 minutes each time, in person or on the telephone
Intervention Type
Drug
Intervention Name(s)
flibanserin
Other Intervention Name(s)
Addyi
Intervention Description
FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women
Primary Outcome Measure Information:
Title
Desire domain of the Female Sexual Function Index (FSFI)
Description
The primary objective of this study is to determine whether efficacy of flibanserin as determined by changes in the desire domain of the Female Sexual Function Index (FSFI) in women who respond to the study medication is greater when sex therapy is performed concomitant with the use of the medication.
Time Frame
at weeks 8 and 20
Secondary Outcome Measure Information:
Title
Female Sexual Distress Scale (FSDS-DAO)
Description
One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the Female Sexual Distress Scale (FSDS-DAO) in women who respond to the study medication.
Time Frame
at weeks 8 and 20
Title
Total score of the Female Sexual Function Index (FSFI)
Description
One secondary endpoint is to determine whether efficacy of flibanserin as determined by changes from baseline in the total FSFI score respectively in women who respond to the study medication.
Time Frame
at weeks 8 and 20
Other Pre-specified Outcome Measures:
Title
Patient Global Impression of Improvement (PGI-I)
Description
The last goal is to identify those women with primary biologic based HSDD who respond to flibanserin and determine whether or not they feel concomitant sex therapy might be more beneficial.
Time Frame
at weeks 8 and 20
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is willing and able to provide written informed consent and HIPAA authorization before any study procedures are conducted;
Subject is female;
Subject is ≥18 years old;
Subject has biologic-based HSDD as her primary sexual complaint;
Subject scores <26 on FSFI and <4.8 on desire domain of FSFI at screening;
Subject scores >18 on FSDS-DAO;
Subject answers yes to questions 1-4 on the DSDS screener;
Subject is willing to use effective contraception during the study if pre-menopausal (oral contraceptives, barrier method, long acting reversible contraceptive, surgical sterilization);
Subject agrees to comply with the study procedures and visits.
Exclusion Criteria:
Subject has sexual pain;
Subject does not have generalized, acquired HSDD;
Subject has used flibanserin in the last 6 months;
Subject has history of alcohol or drug abuse;
Subject uses tobacco in any form;
Subject is currently using androgen therapy and unwilling to washout;
Subject is pregnant, nursing, or planning to become pregnant over the next 6 months;
Subject is taking a moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitor;
Subject is taking a CYP3A4 inducer;
P-glycoprotein substrate;
Subject has a history of liver impairment;
Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study;
Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irwin Goldstein, MD
Organizational Affiliation
San Diego Sexual Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego Sexual Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.sandiegosexualmedicine.com/clinical-trials
Description
Clinical trials at San Diego Sexual Medicine
Learn more about this trial
Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
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