Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: Results from the multicentre, randomised, double-blind, active-controlled HARMONY II study
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The HARMONY II study found that a combined oral contraceptive with estradiol valerate/dienogest reduced hormone withdrawal-associated headaches and pelvic pain more effectively than ethinylestradiol/levonorgestrel.
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Abstract
The objective of this multicentre, randomised, double-blind study was to compare a combined oral contraceptive (COC) containing oestradiol valerate/dienogest (E2V/DNG) administered in a dynamic dosing regimen with a monophasic COC containing ethinyloestradiol/levonorgestrel (EE/LNG), with regard to their ability to reduce the frequency and intensity of headache and pelvic pain in women with hormone withdrawal-associated symptoms (HWAS). Women aged 18-50 years received E2V/DNG in an oestrogen step-down and progestin step-up regimen (26/2 regimen; n = 223) or EE 20 μg/LNG 100 μg (21/7 regimen; n = 218) over six cycles. Headache and pelvic pain were assessed using a visual analogue scale (VAS) during cycle days 22-28. Rescue medication use was also assessed. E2V/DNG was superior to EE/LNG with regard to reducing the frequency and intensity of headache and pelvic pain from baseline to cycle 6 (change from baseline in the average of the three highest VAS values [mean ± standard deviation]: 47.7 ± 29.4 vs 34.5 ± 25.7 mm, respectively; p < 0.0001). The use of rescue medication was also significantly reduced with E2V/DNG compared with EE/LNG (p < 0.05). E2V/DNG may be a good option for women who experience HWAS with traditional 21/7-day regimen COCs.
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Cited by (17)
- Satisfaction of young women with estradiol valerate/dienogest in real clinical practice in Russia: results of prospective multicenter observational study Q-SWAN 2025
- Tolerability of multiphasic and monophasic combined hormonal contraceptives patients with uterine fibroids 2024
- Real clinical practice and contraception for young women with children 2021
- Needs, expectations and doubt users of hormonal contraceptives 2020
- Pooled analysis of bleeding profile, efficacy and safety of oral oestradiol valerate/dienogest in women aged 25 and under 2020
- Uterine bleedings and quality of woman's life 2019
- <p>Contraception with estradiol valerate and dienogest: adherence to the method</p> 2019
- Overview of the therapeutic possibilities of combined oral contraceptive containing estradiol valerate and dienogest 2019
- Estradiol valerate and dienogest in hormonal contraception. Acceptability and effectiveness in real clinical practice 2018
- Continuation rates, bleeding profile acceptability, and satisfaction of women using an oral contraceptive pill containing estradiol valerate and dienogest versus a progestogen-only pill after switching from an ethinylestradiol-containing pill in a real-life setting: results of the CONTENT study 2016
- How to reduce the number of side effects produced by COCs and improve adherence: simple tips for practitioners 2016
- The shorter, the better: A review of the evidence for a shorter contraceptive hormone-free interval 2015
- The influence of oral combined oral contraceptive with estradiol valerate and dienogest on hemostatic system (a review) 2015
- Noncontraceptive benefits of the estradiol valerate/dienogest combined oral contraceptive: a review of the literature 2014
- Pelvic Pain and Quality of Life of Women With Endometriosis During Quadriphasic Estradiol Valerate/Dienogest Oral Contraceptive: A Patient-Preference Prospective 24-Week Pilot Study 2014
- Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea 2014
- Comparison of the pharmacologic and clinical profiles of new combined oral contraceptives containing estradiol 2013
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