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Bitzer J, Banal-Silao MJ, Ahrendt HJ, et al. Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen). Int J Womens Health. 2015;7:501-9doi: 10.2147/IJWH.S77942.
Bitzer, J., Banal-Silao, M. J., Ahrendt, H. J., Restrepo, J., Hardtke, M., Wissinger-Graefenhahn, U., & Trummer, D. (2015). Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen). International journal of women's health, 7501-9. https://doi.org/10.2147/IJWH.S77942
Bitzer, Johannes, et al. "Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen)." International journal of women's health vol. 7 (2015): 501-9. doi: https://doi.org/10.2147/IJWH.S77942
Bitzer J, Banal-Silao MJ, Ahrendt HJ, Restrepo J, Hardtke M, Wissinger-Graefenhahn U, Trummer D. Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen). Int J Womens Health. 2015 May 18;7:501-9. doi: 10.2147/IJWH.S77942. eCollection 2015. PMID: 26056491; PMCID: PMC4445871.
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Int J Womens Health. 2015 May 18;7:501-9. doi: 10.2147/IJWH.S77942. eCollection 2015.

Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen).

International journal of women's health

Johannes Bitzer, Maria Jesusa Banal-Silao, Hans-Joachim Ahrendt, Jaime Restrepo, Marion Hardtke, Ulrike Wissinger-Graefenhahn, Dietmar Trummer

Affiliations

  1. Department of Obstetrics and Gynecology, University Hospital of Basel, Basel, Switzerland.
  2. University of the Philippines College of Medicine, Manila, Philippines.
  3. Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung (Clinical Research and Further Education), Magdeburg, Germany.
  4. Centro de Investigación Clínica, Clinica Medellin Poblado, Medellin, Colombia.
  5. Global Clinical Development Operations, Bayer Pharma AG, Berlin, Germany.
  6. Global Medical Affairs Women's Healthcare, Bayer Pharma AG, Berlin, Germany.
  7. Clinical Statistics Europe, Bayer Pharma AG, Berlin, Germany.

PMID: 26056491 PMCID: PMC4445871 DOI: 10.2147/IJWH.S77942

Abstract

OBJECTIVE: To assess whether the combined oral contraceptive (COC) ethinylestradiol (EE) 20 μg/drospirenone 3 mg taken in a 24/4-day regimen (ie, 4-day hormone-free interval) is more effective than an EE 20 μg/desogestrel (DSG) 150 μg COC taken in a 21/7-day regimen (ie, 7-day hormone-free interval) in reducing hormone withdrawal-associated symptoms (HWAS).

METHODS: This double-blind, randomized study (NLM identifier: NCT01076582) was conducted at 34 centers in 12 countries. Otherwise healthy women who experienced ≥2 HWAS of headache, pelvic pain, and/or bloating when using their current COCs in a 21/7-day regimen were recruited. Subjects rated the severity of their HWAS daily on a seven-point Likert scale during a baseline cycle and during four 28-day cycles with EE/drospirenone 24/4 (n=290) or EE/DSG 21/7 (n=304). The primary variable was the mean change from baseline to cycle 4 in the composite HWAS score (sum of scores for all three symptoms) during cycle days 22-28.

RESULTS: In the EE/drospirenone 24/4 group, the mean (standard deviation) composite HWAS score during cycle days 22-28 was reduced from 42.2 (24.8) at baseline to 12.8 (13.4) at cycle 4 (change from baseline: -30.3 [22.9]). In the EE/DSG 21/7 group, the corresponding value was reduced from 41.9 (25.8) to 14.3 (13.2) (change from baseline: -27.7 [24.8]), not significantly different versus EE/drospirenone 24/4. Bleeding pattern, treatment response, rescue medication use, compliance, quality of life, and tolerability were similar between treatments.

CONCLUSION: Both EE/drospirenone 24/4 and EE/DSG 21/7 reduced the composite HWAS score from baseline to cycle 4 in otherwise healthy women. The differences between treatments were too small to be statistically significant.

Keywords: combined oral contraceptives; desogestrel; drospirenone; ethinylestradiol; hormone withdrawal

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