CompletedPhase 3

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

United States650 participantsStarted 2005-10

Plain-language summary

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

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Superficial cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.

Parabasal cells (by cervical/vaginal cytologic smear) at screening, and weeks 4 and 12.

Trial details

NCT IDNCT00238732

SponsorWyeth is now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Vaginal Atrophy trials