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.