Topical DHEA Against Vaginal Atrophy

EndoCeutics

Status and phase: Completed; Phase 3

Conditions: Vaginal Atrophy

Treatments: Drug: DHEA (0.25%); Drug: Placebo; Drug: DHEA (1.0%); Drug: DHEA (0.5%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01846442

ERC-210

Details and patient eligibility

About

The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.

Enrollment: 218 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
• Women having a vaginal pH above 5
• Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy

Exclusion criteria

• Undiagnosed abnormal genital bleeding
• Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
• The administration of any investigational drug within 30 days of screening visit
• Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
• Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

218 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

0.25% DHEA

Experimental group

Treatment:

Drug: DHEA (0.25%)

0.5% DHEA

Experimental group

Treatment:

Drug: DHEA (0.5%)

1.0% DHEA

Experimental group

Treatment:

Drug: DHEA (1.0%)