CompletedPhase 3

Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

United States, Canada558 participantsStarted 2014-02

Plain-language summary

The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on symptoms of vulvovaginal atrophy due to menopause and to collect further data on subjects exposed to intravaginal DHEA in order to meet the ICH E1 guideline requirements.

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 * Women having ≤5% of superficial cells on vaginal smear at baseline * Women having a vaginal pH above 5 at baseline * Women who have self-identified moderate or severe symptom(s) of vaginal atrophy * Willing to participate in the study and sign an informed consent Exclusion Criteria: Main criteria: * Previous enrollment in EndoCeutics studies performed with intravaginal DHEA * Previous diagnosis of cancer, except skin cancer (non melanoma) * Clinically significant metabolic or endocrine disease (including diabetes mellitus) not controlled by medication * 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

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Vaginal pH

Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT02013544

SponsorEndoCeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

Results submitted2017-03-15

View on ClinicalTrials.gov More Vaginal Atrophy trials

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.

What they're measuring

Change From Baseline to Week 12 in Percentage of Superficial Cells in the Maturation Index of the Vaginal Smear

Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Percentage of Parabasal Cells in the Maturation Index of the Vaginal Smear

Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Vaginal pH

Timeframe: Baseline and Week 12

Change From Baseline to Week 12 in Severity of the Most Bothersome Symptom of Dyspareunia

Timeframe: Baseline and Week 12