The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

Solvay

Status and phase: Terminated; Phase 2

Conditions: Menopause

Treatments: Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg; Drug: Esterified estrogens 1.25 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141557

S030.2.110

Details and patient eligibility

About

To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets

Enrollment: 133 patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg

2

Active Comparator group

Treatment:

Drug: Esterified estrogens 1.25 mg