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Fifty (50) healthy ovulating women aged between 35 and 47 yr (mean age 39) were randomly allocated to one of two groups treated with biphasic formulations of either oestradiol valerate/cyproterone acetate (Group A) or oestradiol valerate/norethisterone (Group B). A double-blind design was used during the first 6 mth of treatment. In Group A, 21 out of 26 women (81%), and in Group B, 16 out of 24 (67%) completed the first year of treatment. No pregnancies occurred.
The mid-cycle serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) peaks were suppressed, but there were no differences between the pretreatment serum oestradiol values and those observed during the treatment cycles. The serum progesterone values indicated that only one ovulatory cycle occurred during the first year in Group A, while there were 11 in Group B. Ultrasonic studies revealed follicular growth during treatment in both groups, most follicles becoming atretic or persistent without ovulation.
No significant changes were observed in 11 coagulation factors studied in 16 women in Group A. Serum total cholesterol decreased by about 10% in both groups.
In Group A bleeding became scantier and dysmenorrhoea disappeared. The incidence of spotting varied between 30% and 40%, but it is important to note that the total number of bleeding days per cycle fell.
The oestradiol valerate/cyproterone acetate combination was thus found to inhibit ovulation, provide tolerable cycle control and to be free from adverse metabolic side effects.
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Accepted: April 7, 1988
Received in revised form: January 29, 1988
Received: September 2, 1987
© 1988 Published by Elsevier Inc.