OBJECTIVE To evaluate the pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after a single subcutaneous injection in the abdomen of 150 or 300 mg Depo-Provera and compare results to two injections of Depo-SubQ Provera 104 given 3 months apart. DESIGN Partially randomized, multicenter, parallel-group study. SETTING Research unit. PATIENT(S) Forty-two women of reproductive age with confirmed ovulatory cycle and body mass index of 18-35 kg/m2. INTERVENTION(S) Women received a single subcutaneous injection of 150 mg (n = 24) or 300 mg (n = 9) of Depo-Provera or two injections of Depo-SubQ Provera 104 (n = 9). MAIN OUTCOME MEASURE(S) Suppression of ovulation as measured by progesterone, serum medroxyprogesterone acetate concentrations, and estimated pharmacokinetics parameters. RESULT(S) No ovulations were observed during 7 months after a single injection of 150 or 300 mg Depo-Provera. The 150 mg group had a similar Cmax as observed over two injection cycles of Depo-SubQ Provera 104 and a similar 6-month trough concentration as the 3-month trough of Depo-SubQ Provera 104. CONCLUSION(S) Our pharmacodynamics and pharmacokinetics data provide proof of concept that Depo-Provera (150 mg) may be an effective contraceptive method when injected subcutaneously every 6 months, with up to a 4-week grace period for reinjections. CLINICAL TRIAL REGISTRATION NUMBER NCT02456584.

中文翻译：

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皮下注射 Depo-Provera 后醋酸甲羟孕酮药代动力学和药效学评价的临床试验

目的 评估在腹部单次皮下注射 150 或 300 mg Depo-Provera 后醋酸甲羟孕酮的药代动力学和药效学，并将结果与​​间隔 3 个月的两次 Depo-SubQ Provera 104 注射的结果进行比较。设计 部分随机、多中心、平行组研究。设置研究单位。患者 42 名已确认排卵周期和体重指数为 18-35 kg/m2 的育龄妇女。干预措施 女性接受单次皮下注射 150 mg (n = 24) 或 300 mg (n = 9) 的 Depo-Provera 或两次注射 Depo-SubQ Provera 104 (n = 9)。主要结果测量通过孕酮、血清醋酸甲羟孕酮浓度和估计的药代动力学参数测量的排卵抑制。结果 在单次注射 150 或 300 毫克 Depo-Provera 后的 7 个月内未观察到排卵。150 mg 组的 Cmax 与 Depo-SubQ Provera 104 的两个注射周期相似，6 个月的谷浓度与 Depo-SubQ Provera 104 的 3 个月谷浓度相似。 结论（S）我们的药效学和药代动力学数据提供概念证明，每 6 个月皮下注射一次 Depo-Provera（150 毫克）可能是一种有效的避孕方法，再注射的宽限期长达 4 周。临床试验注册号 NCT02456584。结论 我们的药效学和药代动力学数据提供了概念证明，即每 6 个月皮下注射一次 Depo-Provera（150 毫克）可能是一种有效的避孕方法，再注射的宽限期长达 4 周。临床试验注册号 NCT02456584。结论 我们的药效学和药代动力学数据提供了概念证明，即每 6 个月皮下注射一次 Depo-Provera（150 毫克）可能是一种有效的避孕方法，再注射的宽限期长达 4 周。临床试验注册号 NCT02456584。