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

NCT ID: NCT00224094

Last Updated: 2012-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Menopause

Keywords

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Menopause Testosterone Androgens Sex Hormone Binding Globulin Thyroid function Cortisol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

Oral ERT then transdermal ERT

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Sequence B

Transdermal ERT then oral ERT

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

42 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan L Shifren, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ALO0102

Identifier Type: -

Identifier Source: org_study_id