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

NCT00224094 — Phase 4, Completed, 27 participants, Watson Pharmaceuticals

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

Registry	NCT00224094
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	27 (Actual)
Sponsor	Watson Pharmaceuticals (Industry); collaborators: Massachusetts General Hospital
Conditions	Menopause
Interventions	Premarin® (oral) vs. Alora® (transdermal) (Drug)
Dates	start 2002-01-01, primary completion 2003-05-01, first posted 2005-09-22, last updated 2012-10-15
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sequence A	Experimental	Drug: Premarin® (oral) vs. Alora® (transdermal)	Oral ERT then transdermal ERT
Sequence B	Experimental	Drug: Premarin® (oral) vs. Alora® (transdermal)	Transdermal ERT then oral ERT

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

+Outcome measures

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. [12 weeks]

Secondary outcomes

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]

+Eligibility

Sex: Female, ages: 42 Years to 70 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
Massachusetts General Hospital	Boston, Massachusetts	United States

+Investigators

Jan L Shifren, MD, Principal investigator, Massachusetts General Hospital