Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

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ClinicalTrials.gov Identifier: NCT02714049

Recruitment Status : Terminated (Company providing Investor Initiated Grant sold drug--new company would not support study.)

First Posted : March 21, 2016

Last Update Posted : February 1, 2019

Sponsor:

Information provided by (Responsible Party):

San Diego Sexual Medicine

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.

Condition or disease	Intervention/treatment	Phase
Hypoactive Sexual Desire Disorder	Behavioral: sex therapy Drug: flibanserin	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	23 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Two Arm Open Label Pilot Study of Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy
Actual Study Start Date :	January 25, 2017
Actual Primary Completion Date :	January 18, 2019
Actual Study Completion Date :	January 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Flibanserin

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: flibanserin Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug	Drug: flibanserin FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women Other Name: Addyi
Experimental: flibanserin and sex therapy 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	Behavioral: sex therapy 60 minutes each time, in person or on the telephone Other Name: psychotherapy Drug: flibanserin FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women Other Name: Addyi

Outcome Measures

Primary Outcome Measures :

Desire domain of the Female Sexual Function Index (FSFI) [ Time Frame: at weeks 8 and 20 ]
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) [ Time Frame: at weeks 8 and 20 ]
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) [ Time Frame: at weeks 8 and 20 ]
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.

Other Outcome Measures:

Patient Global Impression of Improvement (PGI-I) [ Time Frame: at weeks 8 and 20 ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714049

Locations

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United States, California
San Diego Sexual Medicine
San Diego, California, United States, 92120

Sponsors and Collaborators

San Diego Sexual Medicine

Investigators

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Principal Investigator:	Irwin Goldstein, MD	San Diego Sexual Medicine

More Information

Additional Information:

Clinical trials at San Diego Sexual Medicine This link exits the ClinicalTrials.gov site

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Responsible Party:	San Diego Sexual Medicine
ClinicalTrials.gov Identifier:	NCT02714049 History of Changes
Other Study ID Numbers:	SDSM-2015-03
First Posted:	March 21, 2016 Key Record Dates
Last Update Posted:	February 1, 2019
Last Verified:	January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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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

Keywords provided by San Diego Sexual Medicine:


hypoactive sexual desire disorder Addyi flibanserin low sexual desire HSDD

Additional relevant MeSH terms:

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Hypokinesia Sexual Dysfunctions, Psychological Dyskinesias Neurologic Manifestations	Nervous System Diseases Signs and Symptoms Mental Disorders

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