Clinical assessment and quality of life of postmenopausal women treated with a new intermittent progestogen combination hormone replacement therapy: a placebo-controlled study
| Autor: | Michèle Moreau, John R. Hilditch, Morrie M. Gelfand, Normand Ayotte, Betty A Wong, Catherine Y Lau |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
Ethinyl Estradiol-Norgestrel Combination medicine.medical_specialty Canada medicine.medical_treatment Placebo-controlled study Placebo Severity of Illness Index law.invention Quality of life Randomized controlled trial Double-Blind Method law Internal medicine Surveys and Questionnaires medicine Humans Aged Gynecology Estradiol business.industry Estrogen Replacement Therapy Norgestrel Obstetrics and Gynecology Hormone replacement therapy (menopause) Middle Aged medicine.disease Menopause Postmenopause Regimen Drug Combinations Treatment Outcome Hot Flashes Quality of Life Amenorrhea Female medicine.symptom business |
| Zdroj: | Menopause (New York, N.Y.). 10(1) |
| ISSN: | 1072-3714 |
| Popis: | 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; < 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. |
| Databáze: | OpenAIRE |
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