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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224094
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 15, 2012
Massachusetts General Hospital
Information provided by (Responsible Party):
Watson Pharmaceuticals

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : January 2002
Primary Completion Date : May 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sequence A
Oral ERT then transdermal ERT
Drug: Premarin® (oral) vs. Alora® (transdermal)
Experimental: Sequence B
Transdermal ERT then oral ERT
Drug: Premarin® (oral) vs. Alora® (transdermal)

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function. [ Time Frame: 12 weeks ]
  2. Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations. [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   42 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00224094

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Watson Pharmaceuticals
Massachusetts General Hospital
Principal Investigator: Jan L Shifren, MD Massachusetts General Hospital

Responsible Party: Watson Pharmaceuticals Identifier: NCT00224094     History of Changes
Other Study ID Numbers: ALO0102
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by Watson Pharmaceuticals:
Sex Hormone Binding Globulin
Thyroid function

Additional relevant MeSH terms:
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs