Cittadini J, Ben J, Badano A R, Denari H J, Quiroga S, Marcus A E, Schlaen I, Figueroa Casas P R
Reproduccion. 1982 Apr-Jun;6(2):69-79.
A double-blind study was carried out in 60 women with climacteric symptoms: 30 women were given Org OD 14 (2.5 mg) and 30 were given a placebo to be taken daily for six weeks. The effects of the medication on the climacteric symptoms, the subjective sensations, the plasma FSH levels and endometrial histology were studied. In the treated group compared with the control group the relief or improvement of the following climacteric symptoms were recorded: perspiration, palpitations, irritability and backache. A favourable effect on the subjective sensations was noted in both groups, although no significant difference for the group which received Org OD 14 was found. At the end of the treatment with Org OD 14, the FSH levels were found to be greatly reduced in comparison with the basal values; this, however, was not the case with the placebo group. With regard to endometrial histology, no sign of hyperplasia was found in any of the patients. No relevant side effects or symptoms of estrogenic or androgenic stimulation were recorded. For the climacteric patient needing estrogen therapy, it can be concluded that Org OD 14 is an effective and innocuous medication in the doses used.
对60名有更年期症状的女性进行了一项双盲研究:30名女性服用Org OD 14(2.5毫克),30名女性服用安慰剂,每日服用,持续六周。研究了药物对更年期症状、主观感觉、血浆促卵泡激素(FSH)水平和子宫内膜组织学的影响。与对照组相比,治疗组记录到以下更年期症状得到缓解或改善:出汗、心悸、易怒和背痛。两组对主观感觉均有良好影响,尽管未发现服用Org OD 14的组有显著差异。在使用Org OD 14治疗结束时,发现FSH水平与基础值相比大幅降低;然而,安慰剂组并非如此。关于子宫内膜组织学,未在任何患者中发现增生迹象。未记录到相关的副作用或雌激素或雄激素刺激症状。对于需要雌激素治疗的更年期患者,可以得出结论,所使用剂量的Org OD 14是一种有效且无害的药物。