Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera
Depo-Provera (150 mg) injected subcutaneously suppressed ovulation for 7 months in 21 women with body mass index 18–35 kg/m2, suggesting that it may provide effective contraception when injected every 6 months.
Published
VOLUME 115, ISSUE 4, P1035-1043
Authors:
Vera Halpern, M.D., Vivian Brache, B.S., Douglas Taylor, Ph.D., Anja Lendvay, M.P.H., Leila Cochón, B.S., Jeffrey T. Jensen, M.D., M.P.H., Laneta J. Dorflinger, Ph.D.
Abstract:
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.
