A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
- Registration Number
- NCT00224094
- Lead Sponsor
- Watson Pharmaceuticals
- Brief Summary
This study compares the effects of 12 weeks of treatment with transdermal versus oral estrogen therapy on testsoterone levels and thyroid tests in healthy, naturally menopausal women.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
Inclusion Criteria
- Healthy
- Naturally menopausal women
- Aged 42-70 years
- Currently using combination estrogen-progestin replacement therapy
Exclusion Criteria
- Women with contraindications to HRT use, including:Unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events
- Thyroid disease
- Adrenal disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence B Premarin® (oral) vs. Alora® (transdermal) Transdermal ERT then oral ERT Sequence A Premarin® (oral) vs. Alora® (transdermal) Oral ERT then transdermal ERT
- Primary Outcome Measures
Name Time Method Compare the effects of a 12-week course of oral CEE to a 12-week course of transdermal estradiol on free testosterone concentrations in menopausal women. 12 weeks
- Secondary Outcome Measures
Name Time Method Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function. 12 weeks Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations. 12 weeks
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States