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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaginal Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo suppository; once daily for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

DHEA 0.50%

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

Group Type EXPERIMENTAL

DHEA

Intervention Type DRUG

DHEA

DHEA 1.0%

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

Group Type EXPERIMENTAL

DHEA

Intervention Type DRUG

DHEA

DHEA 1.8%

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

Group Type EXPERIMENTAL

DHEA

Intervention Type DRUG

DHEA

Interventions

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DHEA

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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dehydroepiandrosterone; prasterone

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No