Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis: Randomized clinical trial

El Taha L, Lina El Taha, Abu Musa A, Antoine Abu Musa, Khalifeh D, Dalia Khalifeh, Ali Khalil, Khalil A, Abbasi S, Sehrish Abbasi, Nassif J, Joseph Nassif
European journal of obstetrics, gynecology, and reproductive biology · 2021 · vol. 267 , pp. 205–212 · doi:10.1016/j.ejogrb.2021.10.029 · PMID:34826668 · W3211245061
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This randomized clinical trial compared dienogest to combined oral contraceptives for managing endometriosis-associated pain.

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Abstract

ObjectiveTo compare the efficacy of dienogest with the combined oral contraceptive pill (COC) Yasmin for the control of endometriosis-associated pelvic pain.Study designSeventy women with endometriosis-associated chronic pelvic pain, dysmenorrhoea or both for >6 months were randomized to either dienogest (Visanne) 2 mg/day or monophasic COC (Yasmin, 0.03 mg ethinyl estradiol and 3 mg drospirenone) for 24 weeks. The primary efficacy variable was change in non-cyclic pelvic pain and dysmenorrhoea from baseline to end of treatment, assessed using a visual analogue scale (VAS). The secondary efficacy variable was change in the Biberoglu and Behrman (B&B) scale scores for chronic pelvic pain, dysmenorrhoea and dyspareunia. Health-related quality of life (HRQoL) was evaluated using the Endometriosis Health Profile-30 (EHP-30) questionnaire at baseline and 24 weeks. Safety variables included incidence of side-effects, bleeding pattern and treatment tolerability.ResultsBoth treatments improved the mean VAS score for endometriosis-associated pelvic pain significantly: mean difference 6.0 [95% confidence interval (CI) 4.9-7.1; p < 0.0001] in the dienogest group and 4.54 (95% CI 3.1-5.9; p < 0.0001) in the COC group; the difference between them was not significant (p = 0.111). Similarly, both dienogest and COC improved HRQoL in various core and modular segments of the EHP-30 questionnaire with comparable requirements for supplemental pain medication (p = 0.782 and 0.258 at 12 and 24 weeks, respectively), and redistribution of the B&B severity profile for chronic pelvic pain (p = 0.052 and 0.526 at 12 and 24 weeks, respectively), dysmenorrhoea (p = 0.521 and 1 at 12 and 24 weeks, respectively) and dyspareunia (p = 0.376 and 0.835, respectively). Nevertheless, dienogest was associated with fewer side-effects, and hence had a better safety and tolerability profile than COC.ConclusionsDienogest (2 mg/day) is comparable to the COC Yasmin for the relief of endometriosis-associated pelvic pain and improvement in HRQoL.Clinical trial registrationClinicaltrials.gov under number NCT04256200; date of registration 15/1/2020 (registered retrospectively).

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Condition tags

endometriosischronic_pelvic_pain

MeSH descriptors

Endometriosis Endometriosis Endometriosis Nandrolone Nandrolone Nandrolone Contraceptives, Oral, Combined Contraceptives, Oral, Combined Female Humans Pelvic Pain Pelvic Pain Pelvic Pain Quality of Life Retrospective Studies

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