Abstract
Background: Monthly contraceptive injection, which consists of MPA (medroxyprogesterone acetate) mixture with a low-dose estrogen preparate (25 mg MPA and 5 mg estradiol cipionate) is commonly used in Indonesia. It is less practical, because the subjects must visit health services every month. To reduce the imprac- ticality, it has been developed a bi-monthly contraceptive injection of 65 mg MPA and 7.5mg estradi- ol cypionate and a trimonthly contraceptive injection of 120 mg MPA and 10 mg estradiol cypionate. Method: This is a randomized controlled clinical trial - open-label conducted from March 2013 to May 2017 with a total sample of 1080. The study subjects consist of 3 groups. The first group was treated with bi-monthly injections (Injection A), the second group was treated with trimonth- ly injections (Injection B) and the third group was treated with monthly injections (Injection C). The blood pressure, pulse rate and body weight were measured since initial treatment and during each visit for 1 year of treatment. This clinical trial has been registered in the National Agency of Drug and Food Control of the Republic of Indonesia with clinical trial number: PN.01.02.1.31.10.12.6669 Result: No significant differences of blood pressure between each group and during 1 year of in- jection in each group. We found significant differences of weight gain in each group during 1 year of injection (p<0.01), but we did not find significant difference of weight gain be- tween each group. Injection B shows the lowest percentage of dropout cases (1,21%). Conclusion: It can be concluded that bi-monthly injections and trimonth- ly injections are more effective than monthly injections for 12 months of use. They are safe to use, convenient in reducing doctor visits and have a high acceptability.
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