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

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Menopause

Treatments: Drug: Premarin® (oral) vs. Alora® (transdermal)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00224094

ALO0102

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Female

Ages: 42 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Sequence A

Experimental group

Description:

Oral ERT then transdermal ERT

Treatment:

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

Sequence B

Experimental group

Description:

Transdermal ERT then oral ERT

Treatment:

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