Ovulation-inhibiting properties of Org OD 14

Org OD 14 has recently been shown to be an interesting new steroid for the treatment of menopausal women. In view of the importance of treatment of perimenopausal women, in whom ovulation might occur, the aim of the present study was to assess whether or not Org OD 14, administered orally in a daily dose of 2.5 mg for 21 days, inhibits ovulation. Sixteen healthy female volunteers, aged 20-34 years and with established ovulatory cycles, were studied during a control cycle and a treatment cycle. Daily measurements of the plasma levels of FSH, LH, E2, P and PRL were made. Endometrial specimens were obtained from nine of the volunteers between 23rd and 25th day of both cycles. The criteria for an ovulatory cycle were: (1) mid-cycle FSH, LH and E2 peaks; (2) criteria (1) followed by a rise in the P levels of greater than 10 ng/ml; (3) a luteal phase of at least 12 days; (4) biphasic behaviour of E2; and, (5) secretory endometrium on days 23-25 of the cycle. All control cycles were ovulatory. During the treatment the mid-cycle FSH, LH and E2 peaks disappeared, and P levels remained very low. PRL levels showed an occasional moderate rise in some of the volunteers. Endometrial specimens showed a secretory pattern during the control cycle, and different degrees of proliferation during the treatment cycle in all nine volunteers. It was concluded that Org OD 14 inhibited ovulation in all 16 volunteers.