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

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224094
First received: September 14, 2005
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  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:

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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the effects of oral versus transdermal ERT on thyroid binding globulin concentrations and tests of thyroid function. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Compare the effects of oral versus transdermal ERT on cortisol binding globulin and total and free cortisol concentrations. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: January 2002
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  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

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224094     History of Changes
Other Study ID Numbers: ALO0102
Study First Received: September 14, 2005
Last Updated: October 11, 2012
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 23, 2013