G A Bachmann

Dr G A Bachmann, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ, USA; gloria.bachmann@umdnj.edu

STUDY DESIGN

Design:

randomised, placebo-controlled trial.

Allocation:

concealed.*

Blinding:

blinded (patients, healthcare providers, and data collectors).*

STUDY QUESTION

Setting:

48 centres in the USA.

Patients:

425 healthy postmenopausal women ⩾40 years of age (mean age 53 y, mean time since menopause 9 y) who had an average of ⩾7 (mean 10) moderate or severe hot flushes per day for ⩾1 week during screening. Exclusion criteria included abnormal Pap test result, abnormal vaginal bleeding, and a history of thrombophlebitis or thromboembolic disorder.

Intervention:

transdermal patches delivering 0.023 mg/day 17β-oestradiol (E2) plus 0.0075 mg/day levonorgestrel (low-dose group, n = 145), 0.014 mg/day E2 (micro-dose group, n = 147), or no E2 (placebo group, n = 133).

Outcomes:

frequency and severity of hot …