Study of substitution hormonal therapy on cardiovascular diseases in post-menopausal women. A multicentric international collaboration (part I).

UNLABELLED: This is a collaboration begun in a multicentric international study, which proposed to follow (SHT) effects on cardiovascular diseases inpost-menopausal the substitution hormonal therapy women (PMW). OBJECTIVES: Feasibility study of SHT on Romanian PMW (from Bucharest) was based on English working protocol of the coordinator and on the good practice rules. We proposed to include in trial 100-150 PMW. We have solicited 456 women for study participation, age between 45-64 years, which have lesser than 1 year after the stop of menstruation and accepted all conditions to include in study (absence of mammary, uterine, or other cancers, deep venous phlebitis). All conditions were accepted by 121 women. Mean age was 55 +/- 5 years. METHODS: All PMW was randomized in many groups of study. It was administrated either active SHT (estrogens as Progynova, or estrogens and cyproteronate as Climen, both from Schering) or Placebo (Pl) in women grouped: 1. nonhysterectomized (93) randomized for Climen (42) or Pl (42), and hysterectomized (28) randomized for Climen (9), Progynova (9), Pl (10). The effectuated investigations were: clinical history; laboratory data for blood lipids, coagulation, inflammation, cytovaginal control; mammography; osteodensitometry DEXA. Cardiology investigations were: ECG, exercise ECG, echocardiography and Holter registrations in selected case. Control examinations were made at 3 months mean period, excepting mammography and DEXA. RESULTS: After 3 months 46 PMW (38%) retired from the study for: altered first mammography 18 (15%), for side drug reactions (only for Progynova) 8 (7%), for other reasons 20 (17%). CONCLUSIONS: This feasibility study shows that, in Romania, a clinical trial on cardiovascular and general effects of SHT in PMW is possible. But, for realization of the proposed aim of the study to follow up a minimum 600 women in 10 years, we estimate the need of recruitment of 2500-3000 women, which must conform to the protocol conditions.