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

A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00224094
Enrollment
27
Registered
2005-09-22
Start date
2002-01-31
Completion date
Unknown
Last updated
2012-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Menopause, Testosterone, Androgens, Sex Hormone Binding Globulin, Thyroid function, Cortisol

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.

Interventions

DRUGPremarin® (oral) vs. Alora® (transdermal)

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Watson Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
42 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026