drugset / Trial / NCT01608698

Comparison of Body Weight Change During Contraception With Belara and Yasmin

NCT01608698 ↗

Phase 4 Unknown 100 enrolled Mahidol University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate different side effect in contraceptive use of two oral combined contraceptive pills (OCP)in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®), especially body weight change.

Timeline

Start
2012-06
Primary completion
2016-01
Completion
2016-02

Outcome

Met primary endpoint

paper A significant difference was observed in mean body weight change between the EE/CMA and EE/DRSP groups PMID 31756117 ↗

paper baseline to sixth cycle (1.00 ± 1.84 kg vs -0.20 ± 2.23 kg; p = .013). PMID 31756117 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject chlormadinone acetate Small molecule 2 mg Oral
Subject drospirenone Unknown 3 mg Oral
Subject ethinyl estradiol Small molecule 30 ug Oral

Indications

No indication recorded.