Double-blind cross-over study with org OD 14 and placebo in postmenopausal patients

Abstract

A double-blind cross-over study with Org OD 14 was done in 35 post-menopausal patients aged 48–69 years who had hot flushes and other associated symptoms. Patients were randomly allocated to Org OD 14 or to placebo as first treatment. Each period of treatment lasted for 6 weeks and there were no intervals between treatments. Tablets containing 2.5 mg of Org OD 14 or placebo tablets of identical appearance were supplied. Patients took one Org OD 14 tablet or one placebo tablet per day. Data on the following variables were obtained and analyzed statistically: hot flushes, sweating, dizziness, palpitation, tiredness, headache, insomnia, irritability, breathlessness, backache, loss of libido, and mood. Assessment was daily in the case of hot flushes and weekly for the other variables. Org OD 14 was statistically significantly more effective in controlling hot flushes, sweating and headache and tended to be better than the placebo tablets for the other variables.