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

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 C_max 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.

SUBMITTER: Halpern V 

PROVIDER: S-EPMC8051852 | biostudies-literature |

REPOSITORIES: biostudies-literature