DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

Laval University

Status and phase: Completed; Phase 1

Conditions: Vaginal Atrophy

Treatments: Drug: DHEA; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00429806

ERC-213

Details and patient eligibility

About

The purpose of the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration.

Full description

Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.

Therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness of 1.3 mL vaginal suppositories of DHEA at 4 different concentrations (0.0%, 0.5%, 1.0% et 1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy. This is a phase I, randomized, placebo-controlled, double-blind study.

Enrollment: 40 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women,
• Experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity,
• Women having a low maturation index and a vaginal pH above 5,
• Endometrial thickness of 4 mm or less at transvaginal ultrasonography,
• Body weight within 18.5 and 32.0 according to body mass index.

Exclusion criteria

• Undiagnosed abnormal genital bleeding,
• Active or history of thromboembolic disease,
• Significant metabolic or endocrine disease,
• Significant complication on previous hormonal therapy,
• Use of hormonal implants within 6 months prior to study entry,
• Use of oral estrogen, progestin or DHEA in the 8 weeks prior to baseline,
• Use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline,
• Chronic use of corticosteroids,
• Hypertension not controlled by standard therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo suppository; once daily for 7 days.

Treatment:

Drug: Placebo

DHEA 0.50%

Experimental group

Description:

DHEA 0.50% (6.5 mg) suppository; once daily for 7 days.

Treatment:

Drug: DHEA

DHEA 1.0%

Experimental group

Description:

DHEA 1.0% (13 mg) suppository; once daily for 7 days.

Treatment:

Drug: DHEA

DHEA 1.8%

Experimental group

Description:

DHEA 1.8% (23.4 mg) suppository; once daily for 7 days.

Treatment:

Drug: DHEA