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


METHODS
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; < 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; < 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.
Gelfand
Morrie M
MM
Sir Mortimer B. Davis Jewish General Hospital, Montréal, Québec, Canada. mgelfa2@po-box.mcgill.ca
Moreau
Michèle
M
Ayotte
Normand J
NJ
Hilditch
John R
JR
Wong
Betty A
BA
Lau
Catherine Y
CY
D000328:Adult; D000368:Aged; D002170:Canada; D004311:Double-Blind Method; D004338:Drug Combinations; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy; D019304:Ethinyl Estradiol-Norgestrel Combination / Q000008:administration & dosage; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008875:Middle Aged; D009644:Norgestrel / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D017698:Postmenopause; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D004338:Drug Combinations; D009644:Norgestrel; D004958:Estradiol; D019304:Ethinyl Estradiol-Norgestrel Combination; C017576:norgestimate