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

DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I Randomized,Placebo-Controlled, Double-Blind Study.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00429806

Enrollment

Registered

2007-02-01

Start date

2006-11-30

Completion date

2007-07-31

Last updated

2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Atrophy

Keywords

Vaginal atrophy, DHEA, Prasterone, Menopause

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.

Interventions

DRUGDHEA

DHEA

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026