TerminatedPhase 4

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Stopped: Investor Initiated Grant support stopped when drug was sold.

United States23 participantsStarted 2017-01-25

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Desire domain of the Female Sexual Function Index (FSFI)

Timeframe: at weeks 8 and 20

Trial details

NCT IDNCT02714049

SponsorSan Diego Sexual Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-18

View on ClinicalTrials.gov More Hypoactive Sexual Desire Disorder trials

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Flibanserin (Addyi®) vs. Flibanserin and Sex Therapy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria