Pharmacokinetic and Pharmacodynamic Study of Cyclofem

Summary

Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol. The current study will assess the steady-state pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate (MPA) and estradiol (E2) after administration of Cyclofem® and will provide critical information to determine similar bioavailability of Cyclofem to Lunelle in women residing in the United States of America.

Timeline

Start

2010-06

Primary completion

2011-07

Completion

2011-12

Publications

• Thurman A, Kimble T, Hall P, Schwartz JL, Archer DF. Medroxyprogesterone acetate and estradiol cypionate injectable suspension (Cyclofem) monthly contraceptive injection: steady-state pharmacokinetics. Contraception. 2013 Jun;87(6):738-43. doi: 10.1016/j.contraception.2012.11.010. Epub 2012 Dec 22.

Drugs

Indications

No indication recorded.