Status:
COMPLETED
DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
40-75 years
Phase:
PHASE1
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 red...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00429806
Start Date
November 1 2006
End Date
July 1 2007
Last Update
April 7 2017
Active Locations (1)
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1
Clinique des traitements hormonaux CHUL Research Center
Québec, Quebec, Canada, G1V 4G2