Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause

EndoCeutics

Status and phase: Completed; Phase 3

Conditions: Vaginal Atrophy

Treatments: Drug: Placebo; Drug: Prasterone (DHEA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013544

ERC-238

Details and patient eligibility

About

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.

Enrollment: 558 patients

Sex: Female

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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558 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo vaginal ovule daily for 12 weeks

Treatment:

Drug: Placebo

Prasterone

Experimental group

Description:

Prasterone (DHEA) vaginal ovule daily for 12 weeks

Treatment:

Drug: Prasterone (DHEA)