Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

Phase 1 Completed 42 enrolled FHI 360 Asociación Dominicana Pro Bienestar de la Familia, Inc. · collab Oregon Health and Science University · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Timeline

Start: 2015-09
Primary completion: 2018-08-30
Completion: 2018-08-30

Publications

Halpern V, Brache V, Taylor D, Lendvay A, Cochon L, Jensen JT, Dorflinger LJ. Clinical trial to evaluate pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate after subcutaneous administration of Depo-Provera. Fertil Steril. 2021 Apr;115(4):1035-1043. doi: 10.1016/j.fertnstert.2020.11.002. Epub 2021 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	medroxyprogesterone acetate	Other / unclassified	104 mg	Subcutaneous
Subject	medroxyprogesterone acetate	Other / unclassified	150 mg	Subcutaneous
Subject	medroxyprogesterone acetate	Other / unclassified	300 mg	Subcutaneous

Indications

No indication recorded.