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OpenTrials
Completed

NCT Number: NCT00224094

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

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Key information

Conditions

Menopause

Age range

42 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2003
First posted
Sep 22, 2005
Registry last updated
Oct 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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