Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

Wyeth

Status and phase: Completed; Phase 4

Conditions: Vasomotor Symptoms

Treatments: Drug: Tibolone (Livial); Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00472004

0753T-101800

B2481004

Details and patient eligibility

About

This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).

Enrollment: 204 patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy postmenopausal women
• Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
• At least 1 year of natural occurring amenorrhea

Exclusion criteria

• Known or suspected estrogen-dependent neoplasia
• Endometrial hyperplasia
• Any malignancy with the exception of a history of basal cell carcinoma of the skin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

1

Active Comparator group

Description:

17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration

Treatment:

Drug: 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle)

2

Active Comparator group

Description:

Tibolone 2.5 mg 1 daily, 1 year duration

Treatment:

Drug: Tibolone (Livial)