Experimental and clinical data on Cyclabil.

The effects of a 2-phase preparation on the parameters of cycle function were studied in 14 normally menstruating women. The preparation, Cyclabil, is administered in a series of 11 tablets with 2.0 mg oestradiol valerate and 10 tablets with 2.0 mg oestradiol valerate in combination with 0.5 mg D,L-norgestrel. The cervical function, the spinnbarkeit of the cervical mucus and its crystallisability and, by means of RIA, FSH, LH, 17beta-oestradiol and the progesterone serum levels were determined continuously in a control cycle before the treatment, in the first and third treatment cycles and in a subsequent control cycle. The results show that no impairment of the normal cycle function were found during cyclical administration of the 2-phase preparation in 13 women. Two pregnancies occurred during the therapy. The process of ovulation was inhibited in one subject during the medication. 20 other women with pronounced premenopausal deficiency symptoms and cycle irregularities were treated with the 2-phase preparation for 6 months. Apart from the good cycle regulation, the deficiency symptoms were eliminated completely in 19 women and almost completely in 1 woman. Checks of the FSH, LH, 17beta-oestradiol and oestrone serum levels conducted at random during a medication cycle showed only a slight influence on the gonadotropin level. During the medication, E2 can be demonstrated in comparison to E1 at a ratio of 1:10.