Issn Print: 1072-3714

Publication Date: 1999/01/01


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Efficacy and Safety of Low-Dosage Esterified Estrogens Combined with 6-Monthly Progestin: P-14.

B Ettinger; A Pressman; A Vangessel

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Objective: We are investigating menopausal symptoms, vaginal leading and incidence of endometrial hyperplasia in women given hormone replacement ther- apy (HRT) consisting of 0.3 mg/d esterified estrogens (Estratab® combined with wice a year 14-day courses of 10 mg medroxyprogesterone acetate [MPA]). Included were 138 women aged 55-75 years, who had been taking standard cyclic monthly HRT for ≥ year. Menopause symptoms are being evaluated by the Greene Menopause Index (GMI). Vaginal bleeding is reported in subjects' daily diaries. Endometrial safety is monitored by baseline and annual follow-up biopsies.
Results: Subjects mean (SD) age is 60.5 (5.0) years. and they have used HRT 8.9 (5.1) years of the 10.8 (6.1) years since menopause. During an average of 6 months of follow-up, eight subjects have discontinued, seven reporting recrudescence of menopausal symptoms and two reporting unscheduled bleeding. Risk of unscheduled bleeding was 9%. The majority completing the 6 month MPA cycle had no withdrawal bleeding and bleeding, when present, was rarely heavy. The GMI at 3 and 6 months showed statistically significant improvements in psychological and somatic scores while less than 10% of subjects had a worsening vasomotor symptom score. Endometrial biopsy results on 40 subjects will be available.
Conclusions: Women ≥55 years when switching from standard monthly HRT to low-dosage estrogen 6-monthly HRT can expect improvement in somatic and psychological profiles with little risk of worsening vasomotor symptoms. This regimen produces an acceptable menstrual pattern. The study continues to further document endometrial safety.

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