Status:
COMPLETED
Topical DHEA Against Vaginal Atrophy
Lead Sponsor:
EndoCeutics Inc.
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the dose-response of vaginal mucosa parameters to the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from vaginal atrophy.
Eligibility Criteria
Inclusion
- Postmenopausal women (non hysterectomized or hysterectomized)
- Women between 40 and 75 years of age
- Willing to participate in the study and sign an informed consent
- Women having a low maturation index (no greater part of guidance than 5% of superficial cells on vaginal smear)
- Women having a vaginal pH above 5
- Women who have self-identified at least one moderate to severe symptoms of vulvovaginal atrophy
Exclusion
- Undiagnosed abnormal genital bleeding
- Hypertension equal to or above 160/95 mm Hg or not controlled by standard therapy
- The administration of any investigational drug within 30 days of screening visit
- Endometrial hyperplasia at biopsy performed at screening or endometrial cancer
- Use of estrogens/progestins products (vaginal, oral, pellet, transdermal, etc) in the 4 weeks to 6 months (depending on the product used) prior study entry
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT01846442
Start Date
June 1 2007
End Date
October 1 2008
Last Update
August 29 2017
Active Locations (8)
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1
EndoCeutics site # 05
Cleveland, Ohio, United States, 44122
2
EndoCeutics site # 03
Norfolk, Virginia, United States, 23507
3
EndoCeutics site # 10
Montreal, Quebec, Canada, H1T 1P6
4
EndoCeutics site # 09
Montreal, Quebec, Canada, H3A 1A1