A multicentered pharmacokinetic, pharmacodynamic study of once-a-month injectable contraceptives. I. Different doses of HRP112 and of DepoProvera. World Health Organization Task Force on Long-acting Systemic Agents for Fertility Regulation.
A multicentered pharmacokinetic, pharmacodynamic study of once-a-month injectable contraceptives. I. Different doses of HRP112 and of DepoProvera. World Health Organization Task Force on Long-acting Systemic Agents for Fertility Regulation.
复制标题
DOI：
10.1016/0010-7824(87)90093-x
复制
发表时间：
1987-10-01
期刊：
影响因子：
2.9
通讯作者：
Hall, P E
中科院分区：
文献类型：
--
作者：
Garza-Flores, J;Rodriguez, V;Hall, P E
在匈牙利、墨西哥和泰国的三个机构对育龄妇女进行了一项多中心研究，以评价全剂量和半剂量的HRP 112（醋酸甲羟孕酮（DMPA）加环戊丙酸雌二醇）和单独使用DMPA对卵巢功能、出血模式和HDL-胆固醇水平的影响。HRP 112全剂量含DMPA 25 mg+环戊丙酸雌二醇5 mg，半剂量含DMPA 12.5mg+环戊丙酸雌二醇2.5mg。DMPA全量和半量分别为25和12.5mg。总共招募了88名女性参与研究，并在每个中心内随机分配到四个治疗组。受试者被研究了一个控制周期，三个一个月的注射间隔，并随访了另外两个月。在第三次注射间隔期间和两个月的随访期间，每周测定三次雌二醇、孕酮和醋酸甲羟孕酮的血清浓度。虽然所有中心的结果表明，这四种制剂均能有效抑制排卵至少一个月，但各中心的药代动力学特征存在显著差异。在接受雌激素-孕激素联合制剂的妇女中观察到的出血模式比仅接受DMPA的妇女更有规律。
A multicentered study was undertaken at three institutions in Hungary, Mexico and Thailand in women of reproductive age to evaluate the effects of full and half doses of HRP112 (depot-medroxyprogesterone acetate (DMPA) plus estradiol cypionate) and DMPA alone on ovarian function, bleeding patterns and HDL-cholesterol levels. Full dose HRP112 contained 25mg DMPA plus 5mg, of estradiol cypionate and the half dose, 12.5mg DMPA plus 2.5mg of estradiol cypionate. The full and half dose DMPA were 25 and 12.5mg respectively. In all, 88 women were recruited in the study and randomized within each centre, to the four treatment groups. Subjects were studied for a control cycle, three one-month injection intervals and followed-up for a further two months. Serum concentrations of estradiol, progesterone and medroxyprogesterone acetate were determined three times a week during the third injection interval and during the two months of follow-up. While the results from all centres indicated that the four preparations were all effective in inhibiting ovulation for at least one month, there were marked between centre differences in pharmacokinetic profiles. More regular bleeding patterns were observed in women who received the estrogen-progestogen combination preparations than in those who received DMPA alone.