Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy

Completed · Phase 3 · Has a placebo group

Conditions studied: Vaginal Atrophy

In brief

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

Key facts

Study ID

NCT01358760

Run by

EndoCeutics Inc.

People needed

450

Starts

2011-06-01

Expected to finish

2012-05-01

Last updated by the study team

2017-06-12

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Postmenopausal women (non-hysterectomized or 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 baseline and end of study

You may not qualify if…

• 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

Where it is running

• EndoCeutics site # 39 — Montgomery, Alabama, United States
• EndoCeutics site # 14 — Tucson, Arizona, United States
• EndoCeutics site # 65 — Little Rock, Arkansas, United States
• EndoCeutics site # 21 — Sacramento, California, United States
• EndoCeutics site # 30 — San Diego, California, United States
• EndoCeutics site # 36 — Denver, Colorado, United States
• EndoCeutics site # 52 — Denver, Colorado, United States
• EndoCeutics site # 66 — Danbury, Connecticut, United States
• EndoCeutics site # 42 — Milford, Connecticut, United States
• EndoCeutics site # 57 — West Hartford, Connecticut, United States
• EndoCeutics site # 61 — Newark, Delaware, United States
• EndoCeutics site # 26 — Jacksonville, Florida, United States
• EndoCeutics site # 60 — Lake Worth, Florida, United States
• EndoCeutics site # 54 — North Miami, Florida, United States
• EndoCeutics site # 56 — Pinellas Park, Florida, United States
• EndoCeutics site # 23 — Sandy Springs, Georgia, United States
• EndoCeutics site # 10 — Meridian, Idaho, United States
• EndoCeutics site # 55 — Wichita, Kansas, United States
• EndoCeutics site # 27 — Baltimore, Maryland, United States
• EndoCeutics site # 24 — Omaha, Nebraska, United States
• EndoCeutics site # 50 — Neptune City, New Jersey, United States
• EndoCeutics site # 33 — Beachwood, Ohio, United States
• EndoCeutics site # 05 — Cleveland, Ohio, United States
• EndoCeutics site # 47 — Cleveland, Ohio, United States
• EndoCeutics site # 15 — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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