title: Hormone withdrawal-associated symptoms with ethinylestradiol 20 μg/drospirenone 3 mg (24/4 regimen) versus ethinylestradiol 20 μg/desogestrel 150 μg (21/7 regimen).
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Obstetrics and Gynecology, University Hospital of Basel, Basel, Switzerland.
authors.forename: Johannes
authors.initials: J
authors.lastname: Bitzer
authors.affiliation: University of the Philippines College of Medicine, Manila, Philippines.
authors.forename: Maria Jesusa
authors.initials: MJ
authors.lastname: Banal-Silao
authors.affiliation: Praxis für Frauenheilkunde, Klinische Forschung und Weiterbildung (Clinical Research and Further Education), Magdeburg, Germany.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Ahrendt
authors.affiliation: Centro de Investigación Clínica, Clinica Medellin Poblado, Medellin, Colombia.
authors.forename: Jaime
authors.initials: J
authors.lastname: Restrepo
authors.affiliation: Global Clinical Development Operations, Bayer Pharma AG, Berlin, Germany.
authors.forename: Marion
authors.initials: M
authors.lastname: Hardtke
authors.affiliation: Global Medical Affairs Women's Healthcare, Bayer Pharma AG, Berlin, Germany.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Wissinger-Graefenhahn
authors.affiliation: Clinical Statistics Europe, Bayer Pharma AG, Berlin, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Trummer
keywords: combined oral contraceptives; desogestrel; drospirenone; ethinylestradiol; hormone withdrawal