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

This study has been completed.

First Received on September 14, 2005. No Changes Posted

Sponsor:	Watson Pharmaceuticals
Collaborator:	Massachusetts General Hospital
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00224094

Purpose

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.

Condition	Intervention	Phase
Menopause	Drug: Premarin® (oral) vs. Alora® (transdermal)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comparison of Transdermal Vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause Thyroid Diseases

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone Testosterone enanthate Estrogens, conjugated

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

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 Measures:

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.

Estimated Enrollment:	35
Study Start Date:	January 2002

Eligibility

Ages Eligible for Study:	42 Years to 70 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224094

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Watson Pharmaceuticals

Massachusetts General Hospital

Investigators

Principal Investigator:

Jan L Shifren, MD

Massachusetts General Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00224094 History of Changes
Other Study ID Numbers:	2001-P-001476/7; BWH
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:

Menopause
Testosterone
Androgens

Sex Hormone Binding Globulin
Thyroid function
Cortisol

Additional relevant MeSH terms:

Testosterone
Androgens
Estrogens, Conjugated (USP)
Estrogens

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2012