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

Phase 1

Completed

• Conditions: Vaginal Atrophy
• Interventions: Drug: Placebo; Drug: DHEA

• Registration Number: NCT00429806
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2007-03
• Study Completion: 2007-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo suppository; once daily for 7 days.
DHEA 1.0%	DHEA	DHEA 1.0% (13 mg) suppository; once daily for 7 days.
DHEA 0.50%	DHEA	DHEA 0.50% (6.5 mg) suppository; once daily for 7 days.
DHEA 1.8%	DHEA	DHEA 1.8% (23.4 mg) suppository; once daily for 7 days.

Primary Outcome Measures

Name	Time	Method
The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.	Day 1-2 and Day 7-8
The evaluation of the systemic bioavailability of DHEA and its metabolites.	Day 1-2 and Day 7-8

Secondary Outcome Measures

Name	Time	Method
The safety and tolerance of the suppositories.	Day 1 to Day 8 (plus follow-up of Adverse Events for 30 days after last dose)
The effect of treatment on maturation index and value	Day 7

Trial Locations

Locations (1)

Clinique des traitements hormonaux CHUL Research Center; 🇨🇦 Quebec, Canada