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

Abstract

OBJECTIVE:

To compare the efficacy of dienogest with the combined oral contraceptive pill (COC) Yasmin for the control of endometriosis-associated pelvic pain.

STUDY DESIGN:

Seventy 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.

RESULTS:

Both 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.

CONCLUSIONS:

Dienogest (2 mg/day) is comparable to the COC Yasmin for the relief of endometriosis-associated pelvic pain and improvement in HRQoL.

CLINICAL TRIAL REGISTRATION:

Clinicaltrials.gov under number NCT04256200; date of registration 15/1/2020 (registered retrospectively).

• Authors: Lina El Taha, Antoine Abu Musa, Dalia Khalifeh, Ali Khalil, Sehrish Abbasi, Joseph Nassif
• Journal: European journal of obstetrics, gynecology, and reproductive biology (Eur J Obstet Gynecol Reprod Biol) Vol. 267 Pg. 205-212 (Dec 2021) ISSN: 1872-7654 [Electronic] Ireland
• PMID: 34826668 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2021 Elsevier B.V. All rights reserved.

Chemical References

• Contraceptives, Oral, Combined
• dienogest
• Nandrolone

Topics

• Contraceptives, Oral, Combined (adverse effects)
• Endometriosis (complications, drug therapy)
• Female
• Humans
• Nandrolone (adverse effects, analogs & derivatives)
• Pelvic Pain (drug therapy, etiology)
• Quality of Life
• Retrospective Studies