CompletedPhase 3

Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD)

United States, Canada653 participantsStarted 2017-10-16

Plain-language summary

The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.

Who can participate

Age range

40 Years – 80 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 (main criteria): * Postmenopausal women (hysterectomized or not). * Women between 40 and 80 years of age. * Being in a stable relationship with the opportunity for sexual activity or masturbation at least once a month during the last 6 months or longer (before screening visit) and during the following 8 months. * Diagnosis of HSDD confirmed by a qualified clinician. * Willing to participate in the study and sign an informed consent. Exclusion Criteria (main criteria): * Chronic or acute life stress or major life change that could have interfered and continues to interfere significantly with sexual activity. * Taking drugs which could be responsible for HSDD. * Severe medical condition which can explain the loss of sexual desire. * The administration of any investigational drug within 30 days of screening visit. * Clinically significant abnormal serum biochemistry, urinalysis or hematology.

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

Sexual desire

Timeframe: 28 weeks

Distress from low sexual desire

Timeframe: 28 weeks

Trial details

NCT IDNCT03287232

SponsorEndoCeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-08

View on ClinicalTrials.gov More Hypoactive Sexual Desire Disorder trials