Lunelle™ monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension): a contraceptive method for women in the US and worldwide

Abstract

This paper presents data from the first large US clinical trial of Lunelle monthly contraceptive injection, which is a combination of 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C). The lead article reports that there was no occurrence of unintended pregnancies and no contraceptive discontinuation among more than 700 women using the MPA/E2C in a 60-week clinical trial. Most women experienced regular monthly cycles the same as those women using the nonhormonal method. The second article reports the results of a separate trial that studied return ovulation after three monthly injections of MPA/E2C in surgically sterile women. Serum progesterone determinations found that return of ovulation was documented as early as 63 days after the third (final) intramuscular injection of MPA/E2C. Two articles in this issue assess the pharmacokinetics of MPA/E2C injections. Findings indicate that MPA/E2C represents a contraceptive option that combines the advantages of oral contraceptives with the convenience and effectiveness of monthly administration. Accordingly, a US Food and Drug Administration approval should play an important role in helping women achieve effective birth control in the US and worldwide.