Pharmacokinetic and Pharmacodynamic Study of Cyclofem
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.