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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

September 14, 2005
October 11, 2012
January 2002
May 2003   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00224094 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
A Comparison of Patch vs. Pill Estrogen Therapy on Testosterone Levels and Thyroid Tests in Menopausal Women
A Comparison of Transdermal vs. Oral Estrogen Replacement Therapy on Androgen Levels and Thyroid Function in Naturally Menopausal Women

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Menopause
Drug: Premarin® (oral) vs. Alora® (transdermal)
  • Experimental: Sequence A
    Oral ERT then transdermal ERT
    Intervention: Drug: Premarin® (oral) vs. Alora® (transdermal)
  • Experimental: Sequence B
    Transdermal ERT then oral ERT
    Intervention: Drug: Premarin® (oral) vs. Alora® (transdermal)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
May 2003   (final data collection date for primary outcome measure)

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
Female
42 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00224094
ALO0102
Not Provided
Watson Pharmaceuticals
Watson Pharmaceuticals
Massachusetts General Hospital
Principal Investigator: Jan L Shifren, MD Massachusetts General Hospital
Watson Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP