Hormone withdrawal-associated symptoms: Comparison of oestradiol valerate/dienogest versus ethinylestradiol/norgestimate. (August 2013)

• Record Type: Journal Article
• Authors: Jensen, Jeffrey T.; Parke, Susanne; Mellinger, Uwe; Serrani, Marco; Mabey, R. Garn
• Is Part Of: European journal of contraception & reproductive health care. Volume 18:Number 4(2013:Aug.)
• Page Start: 274
• Page End: 283
• Publication Date: 2013-08
• Subjects: Contraception -- Periodicals; Reproductive health -- Periodicals; Generative organs, Female -- Periodicals; Contraception -- Periodicals; Reproductive Medicine -- Periodicals; 613.9
• DOI: 10.3109/13625187.2013.785516
• Languages: English
• ISSNs: 1362-5187

Abstract

<abstract> <title>Abstract</title> <p> <bold>Objectives</bold> To determine the effect of oestradiol valerate/dienogest (E<sub>2</sub>V/DNG) versus ethinylestradiol/norgestimate (EE/NGM) on hormone-withdrawal associated symptoms (HWAS) in otherwise healthy women who had experienced at least one of these symptoms when using 21/7-day combined oral contraceptives (COCs).</p> <p> <bold>Methods</bold> This phase III, parallel-group study randomised 409 women aged 18 to 50 years to E<sub>2</sub>V/DNG or EE/NGM. The primary efficacy variable was the change from baseline to cycle 6 in the average of the three highest visual analogue scale values for headache and/or pelvic pain during cycle days 22 to 28.</p> <p> <bold>Results</bold> In total, 395 were included in the full analysis set (E<sub>2</sub>V/DNG, <italic>n</italic> = 191; EE/NGM, <italic>n</italic> = 204). E<sub>2</sub>V/DNG reduced the symptoms of headache or pelvic pain during cycle days 22 to 28 from baseline to cycle 6 to a significantly greater extent than EE/NGM (mean decrease 43.6 vs. 35.5 mm; <italic>p = </italic> 0.0024). Both treatments were well tolerated with a similar proportion of women experiencing adverse events that were considered at least possibly related to treatment (35% E<sub>2</sub>V/DNG vs. 34% EE/NGM).</p> <p> <bold>Conclusions</bold> E<sub>2</sub>V/DNG reduces the frequency and intensity of headache and pelvic pain to a greater extent than EE/NGM, and may be a good option for women susceptible to HWAS with conventional 21/7-day COCs.</p> </abstract>