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

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Abstract

Introduction

The 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.

Methods

This 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.

Results

Of 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 (32.4% to 6.9%), and in subjects without preceding abortion (12.4% to 5.3%). Incidence of onset of withdrawal bleeding < 7 days among abnormal uterine bleeding patients at baseline was 85.2% and 87.2% at cycles 2 and 5, respectively, and incidence of intra-cyclic bleeding was 23.5% and 8.0% at cycles 1 and 6, respectively. Mean percent change in total acne lesion count from baseline to cycle 6 was − 79.9% ,and mean change in pain severity due to dysmenorrhea was − 31.2 mm at cycle 6 when compared with baseline.

Conclusion

The 24/4 YAZ regimen showed good safety profile, contraceptive reliability, good cycle control along with subgroup of patients. Improvements in dysmenorrhea and acne were also observed. No events of venous thromboembolism/arterial thromboembolism were reported.

Trial Registration

ClinicalTrials.gov identifier, NCT02710708; Center for Drug Evaluation (CDE), China Food and Drug Administration (CFDA) number: CTR20160203.

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Acknowledgements

We thank all the participants of the study.

Funding

This study was funded by Bayer, China. The study sponsor also funded the journal’s Rapid Service Fee.

Medical Writing Assistance

Medical writing support under authors’ direction was provided by Priyanka Bannikoppa, PhD, (Indegene Pvt. Ltd., Bangalore) and funded by Bayer, China.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

List of Investigators

The full list of Investigators for this study can be found in the Supplementary Material.

Disclosures

Fangbo Qian, Yaojuan He, Xiangying Gu, and Wen Di declare that they have nothing to disclose. Xin Sun is an employee of Bayer Healthcare, China.

Compliance with Ethics Guidelines

This study was conducted in accordance with the Declaration of Helsinki, 1964, as revised in 2013 and the International Council for Harmonization guideline E6: Good Clinical Practice. The study was reviewed and approved by each study site’s Independent Ethics Committee (Supplementary Material). Springer’s policy concerning informed consent has been followed. The master ethics committees were the Renji Hospital Shanghai Jiaotong University School of Medicine and Tianjin Medical University General Hospital.

Data Availability

All data generated or analyzed during this study are included in the published article or as supplementary information files.

Author information

Authors and Affiliations

  1. Medical Affairs, Bayer Healthcare, Beijing, China

    Xin Sun

  2. Department of Obstetrics and Gynecology, Wuxi Maternal and Child Health Hospital, Nanjing Medical University, Wuxi, China

    Fangbo Qian

  3. Department of Obstetrics and Gynecology, Guangzhou Women and Children’s Medical Center, Guangzhou, China

    Yaojuan He

  4. Department of Obstetrics and Gynecology, Tianjin Medical University General Hospital, Tianjin, China

    Xiangying Gu

  5. Department of Obstetrics and Gynecology, Renji Hospital Shanghai, Jiao Tong University School of Medicine, Shanghai, China

    Wen Di

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  1. Xin Sun
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Corresponding author

Correspondence to Wen Di.

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Sun, X., Qian, F., He, Y. et al. Safety and Efficacy of Combined Oral Contraceptive Ethinyl Estradiol/Drospirenone (YAZ) in Chinese Women: A Single-Arm, Open-Label, Multicenter, Post-Authorization Study. Adv Ther 37, 906–917 (2020). https://doi.org/10.1007/s12325-019-01210-2

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