Overview

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

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Québec, CHU de Québec
CHU de Quebec-Universite Laval
Treatments:
Dehydroepiandrosterone
Criteria
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.