Status:
COMPLETED
Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Healthy
Estrogen Replacement Therapy
Eligibility:
FEMALE
35-95 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the immunological status of patients using Premarin. Premarin use is associated with an enhanced immune status, and possibly even some anti-cancer effect. The re...
Detailed Description
In recent times, adverse publicity has affected the sales of hormone replacement therapies and the perception of women as to whether or not HRTs should be taken. While a number of brands are available...
Eligibility Criteria
Inclusion
- Women taking oral Premarin at least for the last month with no urogenital anatomical abnormalities.
- Women not taking HRT for at least one month with no urogenital anatomical abnormalities (controls).
Exclusion
- Males.
- Subjects who are not menopausal.
- Less than 35 years of age.
- Subjects with recurrent sexually transmitted disease.
- Subjects with abnormal renal function (serum creatinine \>110umol/l, upper limit 90umol/l) or pyelonephritis.
- Subjects receiving prednisone or immunosuppressive drugs,
- Subjects who need to be treated for any urogenital infection or with any antimicrobial therapy.
- Personal history of known or suspected estrogen-dependent neoplasia such as breast or endometrial cancer.
- Undiagnosed abnormal vaginal bleeding.
- Active hepatic dysfunction or disease, especially of the obstructive type.
- Active thrombophlebitis, thrombosis or thromboembolic disorders.
- Endometrial hyperplasia.
- Subjects on anticoagulants, antidiabetic and antihypertensive agents
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00318318
Start Date
March 1 2006
End Date
February 1 2007
Last Update
July 9 2009
Active Locations (1)
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1
Lawson Health Research Institute
London, Ontario, Canada, N6A 4V2