Overview

Beneficial Effects of Oral Premarin Estrogen Replacement Therapy Assessed by Human Genome Array

Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
0
Participant gender:
Female
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 researchers will compare the use of Premarin with those not using hormone replacement therapy (HRT) to track the effects of Premarin in reducing the risk of infection and swelling.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Lawson Health Research Institute
Treatments:
Estrogens
Estrogens, Conjugated (USP)
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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