NCT02714049

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 25, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

March 11, 2016

Last Update Submit

June 8, 2022

Conditions

Hypoactive Sexual Desire Disorder

Keywords

hypoactive sexual desire disorderAddyiflibanserinlow sexual desireHSDD

Outcome Measures

Primary Outcomes (1)

  • 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.

    at weeks 8 and 20

Secondary Outcomes (2)

  • Female Sexual Distress Scale (FSDS-DAO)

    at weeks 8 and 20

  • Total score of the Female Sexual Function Index (FSFI)

    at weeks 8 and 20

Other Outcomes (1)

  • Patient Global Impression of Improvement (PGI-I)

    at weeks 8 and 20

Study Arms (2)

flibanserin

EXPERIMENTAL

Subjects meeting inclusion/exclusion criteria who respond to flibanserin will have a total of 20 weeks of open label drug

Drug: flibanserin

flibanserin and sex therapy

EXPERIMENTAL

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 therapyDrug: flibanserin

Interventions

sex therapyBEHAVIORAL

60 minutes each time, in person or on the telephone

Also known as: psychotherapy
flibanserin and sex therapy
flibanserinDRUG

FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women

Also known as: Addyi
flibanserinflibanserin and sex therapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego Sexual Medicine

San Diego, California, 92120, United States

Location

Related Links

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Psychotherapyflibanserin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Irwin Goldstein, MD

    San Diego Sexual Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 21, 2016

Study Start

January 25, 2017

Primary Completion

January 18, 2019

Study Completion

January 30, 2019

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)