Status:
COMPLETED
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women
Lead Sponsor:
EndoCeutics Inc.
Conditions:
Vasomotor Symptoms
Hot Flushes
Eligibility:
FEMALE
40-75 years
Phase:
PHASE3
Brief Summary
The purpose of this Phase III trial is to evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vas...
Eligibility Criteria
Inclusion
- Main
- 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 many moderate to severe hot flushes.
- For non-hysterectomized women, willing to have an endometrial biopsy at baseline and end of-study.
- 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 (simple or complex hyperplasia with or without atypia), 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 :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT01452373
Start Date
October 1 2011
End Date
May 1 2013
Last Update
December 11 2013
Active Locations (15)
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1
EndoCeutics site # 06
Bathurst, New Brunswick, Canada, E2A 4X7
2
EndoCeutics site # 70
Burlington, Ontario, Canada, L7M 4Y1
3
EndoCeutics site # 69
Corunna, Ontario, Canada, N0N 1G0
4
EndoCeutics site # 73
Kitchener, Ontario, Canada, N2G 1H6