Study Evaluating Estradiol/Trimegestone in Vasomotor Symptoms (VMS) in Post-Menopausal Women.

Wyeth

Status and phase: Completed; Phase 4

Conditions: Postmenopause

Treatments: Drug: 17b Estradiol; Drug: Trimegestone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195455

0753T-101538

Details and patient eligibility

About

The purpose of this study is to evaluate vasomotor symptoms (VMS) control of the continuous regimen 17 b estradiol/trimegestone combination.

Enrollment: 133 estimated patients

Sex: Female

Ages: 45 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy postmenopausal women 45 to 55 years of age inclusive, with at least 1 year of natural occurring amenorrhea, with vasomotor symptoms, with at least 4 hot flushes per day
• Intact uterus

Exclusion criteria

• Known or suspected breast carcinoma or estrogen-dependent neoplasm
• Undiagnosed abnormal genital bleeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)