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NCT00224094 Clinical Trial

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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00224094
Other study ID # ALO0102
Secondary ID
Status Completed
Phase Phase 4
First received September 14, 2005
Last updated October 11, 2012
Start date January 2002

Study information
Verified date October 2012
Source Watson Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date
Est. primary completion date May 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 42 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Premarin® (oral) vs. Alora® (transdermal)

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Watson Pharmaceuticals Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function. 12 weeks No
Secondary Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations. 12 weeks No
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