A Comparison of Patch Vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
Information source: Watson Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Menopause
Intervention: Premarin® (oral) vs. Alora® (transdermal) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s):
Jan L Shifren, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: A Comparison of Transdermal Vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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.
Secondary outcome: Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.
Eligibility
Minimum age: 42 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: January 2002
Last updated: September 14, 2005
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