Status:
COMPLETED
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Lead Sponsor:
EndoCeutics Inc.
Conditions:
Vaginal Atrophy
Eligibility:
FEMALE
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years...
Eligibility Criteria
Inclusion
- Main
- Postmenopausal women (non-hysterectomized)
- Women between 40 and 75 years of age.
- Willing to participate in the study and sign an informed consent.
- Women who have self-identified symptom(s) of vaginal atrophy.
- Willing to have endometrial biopsy at screening and end of study (Week 52).
- Main
Exclusion
- Undiagnosed abnormal genital bleeding.
- Hypertension equal to or above 140/90 mm Hg.
- The administration of any investigational drug within 30 days of screening visit.
- Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT01256671
Start Date
December 1 2010
End Date
December 1 2012
Last Update
October 18 2017
Active Locations (41)
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1
EndoCeutics site # 39
Montgomery, Alabama, United States, 36117
2
EndoCeutics site # 14
Tucson, Arizona, United States, 85712
3
EndoCeutics site # 21
Sacramento, California, United States, 95821
4
EndoCeutics site # 30
San Diego, California, United States, 92108