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

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

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1035-1043
Number of pages9
JournalFertility and sterility
Volume115
Issue number4
DOIs
StatePublished - Apr 2021

Keywords

  • Depot medroxyprogesterone acetate
  • contraception
  • pharmacokinetics
  • subcutaneous
  • suppression of ovulation

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

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