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

S

Solvay

Status and phase

Terminated
Phase 2

Conditions

Menopause

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141544
S030.2.107

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

Female

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Non-hysterectomized, menopausal women between the ages of 35 and 65 years (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

28 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: esterified estrogens 1.25 mg and methyltestosterone 2.5 mg
2
Active Comparator group
Treatment:
Drug: Esterified estrogens 1.25 mg

Trial contacts and locations

78

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Data sourced from clinicaltrials.gov

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