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Clinical assessment and quality of life of postmenopausal women treated with a new intermittent progestogen combination hormone replacement therapy: a placebo-controlled study

Gelfand, Morrie M. MD1; Moreau, Michèle MD2; Ayotte, Normand J. MD3; Hilditch, John R. MD4; Wong, Betty A.5; Lau, Catherine Y. PhD5


Objective The aim of this study was to evaluate the effects of a constant-estrogen, intermittent-progestogen hormone replacement regimen (Ortho-Prefest, Ortho-McNeil Pharmaceutical, Raritan, NJ, USA) on menopausal symptoms measured by the Kupperman Index and on quality of life measured by the Menopause Quality of Life-Intervention questionnaire.

Design This was a randomized, double-blind, placebo-controlled multicenter study of 90 days' duration. Nonhysterectomized, postmenopausal women with vasomotor symptoms and at least 6 months' amenorrhea were eligible. On completion of the placebo-controlled portion of the study, participants could elect to receive active treatment for an additional 90 days.

Results The study enrolled 119 participants, 59 and 60 in the Prefest and placebo groups, respectively. A marked reduction of menopausal symptoms, as measured by the Kupperman Index, was observed in the active treatment group compared with the placebo group after 45 days' treatment (mean reduction, 14.8 v 7.2 points, respectively), which was sustained to day 90 (16.8 v 7.8 points;P < 0.001). Similarly, greater improvement in quality of life, as measured by the Menopause Quality of Life summary score, was also observed in the active treatment group for the same period (improvement of up to 1.6 points v 0.7 points;P < 0.001). The adverse event profile was unremarkable. Of the 114 participants who received the active treatment, 6 withdrew because of adverse events.

Conclusions The constant-estrogen, intermittent-progestogen regimen was highly effective in relieving menopausal symptoms and in improving quality of life and was well received by the study participants.

From the 1Sir Mortimer B. Davis Jewish General Hospital, Montréal, Québec, Canada; 2Centre Hospitalier de l'Université de Montréal, Montréal, Québec, Canada; 3Centre Hospitalier du Centre de la Mauricie, Shawinigan, Québec, Canada; 4Sunnybrook and Women's College Health Science Centre, Toronto, Ontario, Canada; 5Janssen-Ortho Inc., Toronto, Ontario, Canada.

Received April 11, 2002; revised and accepted July 10, 2002.

This work was supported by Janssen-Ortho Inc., Toronto, Ontario, Canada.

Address reprint requests to Morrie M. Gelfand, MD, Sir Mortimer B. Davis Jewish General Hospital, 5750 Côte des Neiges Road, Suite 630A, Montréal, Québec H3S 1Y9, Canada. E-mail:

©2003The North American Menopause Society