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

A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141557

Enrollment

133

Registered

2005-09-01

Start date

2004-07-31

Completion date

2008-03-31

Last updated

2008-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Menopause; Postmenopause; Estrogen; Hormone Therapy

Brief summary

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

Interventions

DRUGesterified estrogens 1.25mg and methyltestosterone 2.5mg

ESTRATEST® administered orally QD

DRUGEsterified estrogens 1.25 mg

Esterified estrogens 1.25 mg administered orally QD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

35 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in the total score of the Menopause Rating Scale (MRS)	12 weeks

Secondary

Measure	Time frame
Change from baseline in the domain and individual item scores of the MRS	12 weeks
Change from baseline in the domain scores of the MENQOL	monthly for 3 months
Comparison of changes in hormone levels and correlation with changes in the MRS	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026