A Phase 3 interventional study of Placebo Vaginal Insert and Prasterone 6.5 mg (0.50%) Vaginal Insert in Hypoactive Sexual Desire Disorder (HSDD), sponsored by EndoCeutics Inc.. Withdrawn at 10 sites in United States. Open to female participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by EndoCeutics Inc. · Phase 3, Interventional, and Treatment
The primary objective is to confirm the efficacy of intravaginal prasterone (DHEA) on Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women.
138 studies on the registry are indexed under Sexual Dysfunctions, Psychological; 10 are open to participants now.
Browse Sexual Dysfunctions, Psychological studies →EndoCeutics Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria (main criteria):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo Vaginal Insert
Drug: Prasterone 6.5 mg (0.50%) Vaginal Insert
Daily administration of a placebo vaginal insert.
Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
Sexual desire
Change from Baseline in sexual desire as evaluated by Questions 1 \& 2 of the 19-items questionnaire titled Female Sexual Function Index (FSFI). For this outcome, Question 1 and Question 2 (corresponding to the desire domain) will be graded from 1 to 5 (score range) and then be multiplied by 0.6 (domain factor). The desire domain (sum of scores from Questions 1 \& 2) has a minimum score of 1.2 and a maximum score of 6. Higher values represent a better outcome.
Time frame: 28 weeks
Distress from low sexual desire
Change from Baseline in distress from low sexual desire as evaluated by Question 13 of the 15-items questionnaire titled Female Sexual Distress Scale - Desire Arousal Orgasm (FSDS-DAO). For this outcome, Question 13 is graded from 0 to 4 and a lower value represents a better outcome.
Time frame: 28 weeks
Satisfying sexual events (SSEs)
Change from Baseline in the number of SSEs from a daily log of sexual activity.
Time frame: 28 weeks
Plan to share: No
Ran from Nov 2018 to primary completion in Aug 2019, 9 months.
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This study is withdrawn, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dehydroepiandrosterone
Sexual Dysfunctions, Psychological →
EndoCeutics Inc.