Once-a-month injectable contraceptives, Cyclofem and Mesigyna, in Egypt. Efficacy, causes of discontinuation, and side effects.

A clinical trial of the two once-a-month injectable contraceptives, Cyclofem and Mesigyna, used for 1 year was carried out in Egypt involving a total of 2252 women living in different Egyptian localities, representing urban/rural and Upper/Lower Egyptian populations. Women were randomly assigned to either one of the two study preparations and followed a standard protocol for a comparative assessment of the efficacy, side effects, and acceptability of the two preparations. Both contraceptives proved to be highly acceptable, with continuation rates of 63.2 per 100 women-years for Cyclofem and 61.6 for Mesigyna at the end of 12 months of use. The cumulative discontinuation rates per 100 women-years for method failure were 0.19 for Cyclofem users and 0.41 for Mesigyna users. Menstrual problems were the most frequently reported side effects in both groups. Discontinuation rates because of amenorrhea were 2.74 in the Cyclofem group compared to 1.38 in the Mesigyna group, whereas the rates of discontinuation because bleeding problems were significantly higher among Mesigyna users (11.54) compared to the Cyclofem group (7.39). There was no significant difference between the two groups regarding the discontinuation rates from other medical and personal causes. There were insignificant changes in the systolic and diastolic blood pressure values recorded at follow-up; only one Cyclofem user developed systemic hypertension (160/100 mm Hg) after 6 months of use and was discontinued for that reason. On the other hand, a constant weight gain averaging 0.33 kg/month was observed in both groups; however, weight gain was not considered a major cause of method discontinuation.

RCT Entities:   Population Interventions Outcomes