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A randomized, placebo- and active-controlled trial of bazedoxifene/conjugated estrogens for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women

Kagan, Risa MD, FACOG1; Williams, R. Stan MD2; Pan, Kaijie MS3; Mirkin, Sebastian MD3; Pickar, James H. MD3

doi: 10.1097/gme.0b013e3181b7c65f
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Objectives: The primary objective of the Selective estrogen Menopause And Response to Therapy 3 (SMART-3) trial was to compare the efficacy and safety of two doses of bazedoxifene (BZA)/conjugated estrogens (CE) versus placebo for the treatment of moderate to severe vulvar/vaginal atrophy (VVA) associated with menopause.

Methods: This was a phase 3, multicenter, double-blind, randomized, placebo-controlled, and active comparator-controlled study. Healthy postmenopausal women (n = 664; aged 40-65 y) were randomized to BZA 20 mg/CE 0.625 mg, BZA 20 mg/CE 0.45 mg, BZA 20 mg, or placebo once daily for 12 weeks. Changes in vaginal maturation, vaginal pH, and severity of the most bothersome symptom of VVA from baseline were assessed at screening and at weeks 4 and 12. Adverse events were recorded throughout the study.

Results: BZA 20 mg/CE 0.625 or CE 0.45 mg significantly (P < 0.01) increased superficial cells and decreased parabasal cells compared with placebo. Vaginal pH and most bothersome symptom significantly improved with BZA 20 mg/CE 0.625 mg compared with placebo (P < 0.05). Improvements in vaginal dryness were also observed with both BZA/CE doses (P < 0.05). The incidence of treatment-related adverse events were similar across treatment groups.

Conclusions: BZA/CE is effective in treating moderate to severe VVA and vaginal symptoms. These data further support the use of a tissue-selective estrogen complex containing BZA/CE as a new menopausal therapy for postmenopausal women.

From the 1Foundation for Osteoporosis Research and Education, Oakland, CA; 2University of Florida, Gainesville, FL; and 3Wyeth Research, Collegeville, PA.

Received June 6, 2009; revised and accepted July 15, 2009.

Financial support: Wyeth Research, Collegeville, PA, sponsored the study and supported the medical writing assistance of Kathleen Ohleth, PhD, and Chastity Bradley, PhD.

Financial disclosure/conflicts of interest: Dr. Risa Kagan received research grants from Proctor & Gamble, Lilly, Boehringer Ingelheim, Depomed, and Wyeth. Dr. Kagan is a consultant for Proctor & Gamble, Lilly, Medtronic, and Wyeth and is a speaker for GlaxoSmithKline, Roche, Novogyne, Novartis, and Lilly. Dr. Williams received research grants from Wyeth, Xanodyne, and Organon and is also a speaker for Wyeth. Drs. Mirkin and Pickar and Kaijie Pan are full-time employees of Wyeth Research, Collegeville, PA.

Address correspondence to: Risa Kagan, MD, FACOG, East Bay Physicians Medical Group, 2915 Telegraph Ave 200, Berkeley, CA 94705. E-mail: kaganr@sutterhealth.org

©2010The North American Menopause Society