Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00318318
Eligibility 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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
95 Years
Study:
NCT00318318
Study Brief:
Protocol Section:
NCT00318318