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Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera

2021; Elsevier BV; Volume: 115; Issue: 4 Linguagem: Inglês

10.1016/j.fertnstert.2020.11.002

1556-5653

Vera Halpern, Vivian Brache, Douglas Taylor, Anja Lendvay, Leila Cochón, Jeffrey T. Jensen, Laneta J. Dorflinger,

Maternal and fetal healthcare

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.Partially randomized, multicenter, parallel-group study.Research unit.Forty-two women of reproductive age with confirmed ovulatory cycle and body mass index of 18-35 kg/m2.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).Suppression of ovulation as measured by progesterone, serum medroxyprogesterone acetate concentrations, and estimated pharmacokinetics parameters.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.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.NCT02456584.