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

• Published in: International journal of women's health 2015-05, Vol.7 (default), p.501-509
• Main Authors: Bitzer, Johannes, Banal-Silao, Maria Jesusa, Ahrendt, Hans-Joachim, Restrepo, Jaime, Hardtke, Marion, Wissinger-Graefenhahn, Ulrike, Trummer, Dietmar
• Format: Article
• Language: English
• Subjects: Birth control; Complications and side effects; Desogestrel; Dosage and administration; Drospirenone; Drug withdrawal symptoms; Ethinyl estradiol; Headaches; Likert scale; Menstruation; Pain; Quality of life; Questionnaires; Risk factors; Standard deviation; Variables
• ISSN: 1179-1411; 1179-1411
• DOI: 10.2147/IJWH.S77942

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, ethinylestradiol, drospirenone, desogestrel, hormone withdrawal