A study of efficacy, safety, and acceptance of two combined oral contraceptive pills containing 150 mcg Levonorgestrel and 30 mcg Ethinyl Estradiol at Dr. Kariadi Hospital, Semarang, Indonesia

Abstract

Background: Combine Oral Contraceptives (COCs) pills is one of the many popular contraceptives worldwide, with 100 million women who use contraceptive pills. To increase the choice of oral contraceptives, COCs Novadiol® (Pill A) domestic production, which has the same dosage as Microgynon® (Pill B), are still imported drugs. This study aims to determine Pill A's efficacy, safety and acceptance level compared to Pill B for 3 months. Methods: The study was a randomized control clinical trial, an open-label trial in 200 women of childbearing age who met the inclusion and exclusion criteria from July to November 2015. Data were analyzed using SPSS version 20 for Windows. Results: About 300 participants were selected and 200 met the inclusion and exclusion criteria who participated study from the beginning to the end of the study period. In the first month of observation, 1 complaint of dizziness in pill A and 2 from pill B. One nausea complaint was found in the participant from Pill A. These differences were not statistically significant (p>0.05). In the second month of observation, 1 complained of dizziness from pill B and 1 nausea from Pill A. In the third month, observation found no complaints about using Pill A and pill B. There were changes in menstrual patterns in both pills and bleeding outside the cycle during the use of 3 months, but they were not statistically significant (p>0.05). Conclusion: Pills A has the same efficacy, safety and acceptance when compared to the use of birth control pills B for 3 months.