A Prospective Double-blind One-year Study of Nylestriol （CEE3） on Preventing Bone Loss in Postmenopausal Women

A prospective, double-blind clinical study has been carried out in 90 Chinese women with YSM (years since menopause) coverage of 0.5—21 by administering a synthetic longacting estriol derivative-Nylestriol (CEE3) in the dosage of 2mg every 2 weeks for I year (49 treated and 41 placebo). The result were: (1). Serum alkaline phosphatase (ALP); ratios of calcium to creatinine (Ca/Cr) and hydroxyproline to creatinine (Hop/Cr) in fasting morning urine decreased significantly after 3 months of treatment (P＜0.05). (2). The menopause-related reduction rates of forearm bone mineral content (PBMC, DBMC) and bone density (PBD, DBD) were restrained, with 1.0～5.7% increased in those women with YSM beyond 5. (3). FSH were found decreased only in the treated group with YSM beyond 5 (P＜0.01); which was in consistent with the change of bone mass. LH did not change significantly in all groups (P＞0.05). (4). CEE3 exhibited slight side effects. 7 subjects bad breakthrough bleeding (10.3%). 1/3 of the women with intact uterus had spotly withdrawal bleeding and another 1/3 had moderate amount after the addition of medroxypiogesterone acetate (MPA) 6 mg daily for 7 days at the end of the 12 months of CEE3 treatment. The study has demonstrated that Nylestriol is a kind of effective, convenient and longacting estrogen for preventing postmenopausal bone loss. The long-term application need further observation.