Study Evaluating Bazedoxifene/Conjugated Estrogen Combinations in Vasomotor Symptoms Associated With Menopause

Wyeth

Status and phase: Completed; Phase 3

Conditions: Vaginal Atrophy

Treatments: Drug: Bazedoxifene/Conjugated Estrogen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00238732

3115A1-306

Details and patient eligibility

About

The purpose of this study is to determine whether Bazedoxifine/conjugated estrogens are effective in the treatment of vaginal atrophy.

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Generally healthy, postmenopausal women, aged 40 to 65 years
• Intact uterus
• At least 1 moderate to severe vulvar/vaginal symptom that is most bothersome

Exclusion criteria

• Hypersensitivity to estrogens, endometrial hyperplasia, known or suspected estrogen-dependent neoplasia
• Thrombophlebitis, thrombosis or thromboembolic disorders
• Neuro-ocular disease

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind