Franchimont P, Franchi F, Luisi M, Kicovic P M
Reproduccion. 1982 Apr-Jun;6(2):61-7.
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.
最近研究表明,Org OD 14是一种用于治疗绝经后女性的新型甾体药物,具有潜在的研究价值。鉴于围绝经期女性治疗的重要性,且该阶段仍可能发生排卵,本研究旨在评估每日口服2.5 mg Org OD 14,连续服用21天,是否能抑制排卵。选取16名年龄在20 - 34岁、排卵周期规律的健康女性志愿者,分别在对照周期和治疗周期进行研究。每日检测血浆中促卵泡生成素(FSH)、促黄体生成素(LH)、雌二醇(E2)、孕酮(P)和催乳素(PRL)的水平。在两个周期的第23至25天,从9名志愿者获取子宫内膜样本。排卵周期的判定标准为:(1)周期中期FSH、LH和E2出现峰值;(2)满足标准(1)后,P水平升高超过10 ng/ml;(3)黄体期至少12天;(4)E2呈双相变化;(5)周期第23 - 25天子宫内膜呈分泌期改变。所有对照周期均为排卵周期。治疗期间,周期中期FSH、LH和E2峰值消失,P水平维持在极低水平。部分志愿者的PRL水平偶尔出现中度升高。9名志愿者的子宫内膜样本在对照周期呈分泌期改变,治疗周期则呈现不同程度的增殖。研究得出结论,Org OD 14可抑制所有16名志愿者的排卵。