CompletedPhase 3

DHEA Against Vaginal Atrophy - 3-Month Efficacy Study

United States255 participantsStarted 2010-12

Plain-language summary

The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.

Who can participate

Age range40 Years – 75 Years

SexFEMALE

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

Main Inclusion Criteria: * Postmenopausal women (hysterectomized or non-hysterectomized) * Women between 40 and 75 years of age. * Willing to participate in the study and sign an informed consent. * Women who have self-identified symptom(s)of vaginal atrophy. * For non-hysterectomized women, willing to have endometrial biopsy at screening and end of study. Main Exclusion Criteria: * Undiagnosed abnormal genital bleeding. * Hypertension equal to or above 140/90 mm Hg. * The administration of any investigational drug within 30 days of screening visit. * Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.

What they're measuring

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 Percentage of Superficial 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 IDNCT01256684

SponsorEndoCeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08

Results submitted2017-03-14

View on ClinicalTrials.gov More Vaginal Atrophy trials