A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women

Watson Pharmaceuticals27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Menopause

Interventions

Premarin® (oral) vs. Alora® (transdermal)DRUG

Eligibility

Sex: FEMALEMin age: 42 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function.

Time frame: 12 weeks

Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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