Clinical acceptability of monophasic gestodene.

Abstract

The monophasic low-dose contraceptive containing 30 micrograms of ethinyl estradiol and 75 micrograms of gestodene has been tested in numerous clinical studies to determine contraceptive reliability, cycle control, and influence on metabolism and to uncover concomitant symptoms. Clinical data have been derived from continuous phase III studies. Now that the preparation has been introduced in several countries, the opportunity to assemble comprehensive experience has been taken by initiating phase IV studies. Documentation on 600,000 therapy cycles with monophasic gestodene among 100,000 women is already available. The drop-out rate was low. A large number of women participated in the clinical studies for a long time--some up to 3 years. Study results showed that contraceptive reliability was high and cycle control was excellent. The gestodene combination was well tolerated. The frequency of concomitant symptoms was low. The monophasic gestodene meets the basic criteria essential for an oral contraceptive.