Safety and Efficacy of Combined Oral Contraceptive Ethinyl Estradiol/Drospirenone (YAZ) in Chinese Women: A Single-Arm, Open-Label, Multicenter, Post-Authorization Study

AbstractIntroductionThe study was conducted to assess the safety and efficacy of a combined oral contraceptive, YAZ, containing 3  mg drospirenone/20 μg ethinyl estradiol administered in a 24/4 regimen.MethodsThis was a single-arm, open-label, interventional, post-authorization safety surveillance study of YAZ across 6 treatment cycles. Primary objective was assessing its safety profile in Chinese women. Secondary objectives included assessing contraceptive efficacy, cycle control, and bleeding patterns among subjects with and without preceding abortion, along with efficacy in moderate acne vulgaris. Subgroup analyses included assessing efficacy in the dysmenorrhea group using a visual analog scale. All variables were analyzed by descriptive statistical methods.ResultsOf 1921 women treated with YAZ (mean age: 29.9  ± 5.5 years), 12.9% reported adverse drug reactions. Most frequently reported adverse events were nausea (2.6%), breast pain (2.3%), and breast swelling (1.3%). Unintended pregnancy rate (adjusted Pearl Index) was 0.3 (n = 2 pregnancies, 95% confidence interval 0.1–1.2). Incidence of overall withdrawal bleeding (cycle 2–cycle 5) was 93.3%–95.2%, of which 87.8%–95.1% in post-abortion subjects and 94.0%–95.3% in subjects without preceding abortion. Intra-cyclic bleeding (cycle 2–cycle 6) decreased in the overall population (from 14.9 to 5.5%), post-abortion subgroup (32...
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research

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