Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

Completed · Phase 3 · Has a placebo group

Conditions studied: Vaginal Atrophy

In brief

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.

Key facts

Study ID

NCT02013544

Run by

EndoCeutics Inc.

People needed

558

Starts

2014-02-01

Expected to finish

2015-02-01

Last updated by the study team

2017-06-01

Who can join

Age: 40 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• EndoCeutics site # 39 — Montgomery, Alabama, United States
• EndoCeutics site # 14 — Tucson, Arizona, United States
• EndoCeutics site # 21 — Sacramento, California, United States
• EndoCeutics site # 83 — San Diego, 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 # 45 — Boynton Beach, Florida, United States
• EndoCeutics site # 60 — Lake Worth, Florida, United States
• EndoCeutics site # 54 — North Miami, Florida, United States
• EndoCeutics site # 80 — West Palm Beach, Florida, United States
• EndoCeutics site # 23 — Atlanta, Georgia, United States
• EndoCeutics site # 55 — Wichita, Kansas, United States
• EndoCeutics site # 86 — Louisville, Kentucky, United States
• EndoCeutics site # 27 — Lutherville, Maryland, United States
• EndoCeutics site # 87 — Lawrenceville, New Jersey, United States
• EndoCeutics site # 81 — Plainsboro, New Jersey, United States
• EndoCeutics site # 05 — Cleveland, Ohio, United States
• EndoCeutics site # 15 — Columbus, Ohio, United States
• EndoCeutics site # 75 — Philadelphia, Pennsylvania, United States
• EndoCeutics site # 84 — Corpus Christi, Texas, United States
• EndoCeutics site # 82 — Houston, Texas, United States
• EndoCeutics site # 03 — Norfolk, Virginia, United States
• EndoCeutics site # 76 — Seattle, Washington, United States
• EndoCeutics site # 85 — Burlington, Ontario, Canada

Full record on ClinicalTrials.gov

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