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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain transdermal vs. oral estrogen's differential impact on testosterone levels in menopausal women?
How does Alora® transdermal estrogen compare to Premarin® in maintaining thyroid function during menopause?
Which biomarkers correlate with improved androgen levels following transdermal estrogen therapy in NCT00224094?
What adverse events are associated with transdermal estrogen delivery in menopausal women compared to oral formulations?
Are there combination therapies with transdermal estrogen that enhance thyroid function in postmenopausal women?
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital🇺🇸Boston, Massachusetts, United States