Evaluation of the efficacy and tolerability of 4 mg dienogest in women with adenomyosis and BMI >30

Authors

  • M. Madhubala Manickavasagam Department of Obstetrics and Gynecology and Fertility Care Centre, Lakshmi Madhavan Hospital, Tirunelveli, Tamil Nadu, India
  • M. Ramalakshmi Department of Obstetrics and Gynecology and Fertility Care Centre, Lakshmi Madhavan Hospital, Tirunelveli, Tamil Nadu, India
  • R. Jeyajanani Department of Obstetrics and Gynecology and Fertility Care Centre, Lakshmi Madhavan Hospital, Tirunelveli, Tamil Nadu, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20251562

Keywords:

Adenomyosis, Dienogest, Dysmenorrhea, Menorrhagia, Pharmacokinetics, Obesity, BMI >30, Hormonal therapy, Lifestyle modifications, Progestin therapy

Abstract

Background: To evaluate the efficacy and tolerability of 4mg dienogest in women with adenomyosis and BMI >30.

Methods: This prospective study, conducted at Lakshmi Madhavan Hospital Pvt Ltd, Tirunelveli, Tamil Nadu, between January and October 2023, included 110 women aged 30-40 years diagnosed with adenomyosis via ultrasonography and presenting with severe dysmenorrhea. These women, all with BMI >30, were administered 4mg Dienogest (2mg twice daily) for eight weeks, followed by a taper to 2mg once daily for 12 weeks. All participants received dietary counselling emphasizing reduced carbohydrate intake and lifestyle modifications. Data on symptom improvement, adverse effects, and adherence were collected and analyzed using STATA 11.0.

Results: A significant improvement in symptoms such as menorrhagia, dysmenorrhea, dyspareunia, and chronic pelvic pain was observed in 81% of participants. Adverse effects, including headache (15%), breast discomfort (10%), and mild weight gain (8%), were reported but were well-tolerated. Irregular bleeding led to discontinuation in 3% of cases. Women requiring the 4mg dose beyond eight weeks demonstrated poor adherence to dietary modifications. The overall success rate was 81% (n=89), with a failure rate of 19% (n=21).

Conclusion: The study suggests that a higher dosage of Dienogest (4mg) for a limited period is effective and well-tolerated in obese women with adenomyosis who do not respond to the standard 2 mg dose. However, individualized treatment and strict lifestyle adherence are essential for optimal outcomes.

Metrics

Metrics Loading ...

References

Naik R, Karmali D, Nagarsenkar A, Mainath S, Pednekar G. Effect of Pre-pregnancy Maternal Body Mass Index on Obstetric Outcomes in a Tertiary Care Hospital in Goa, India. J Obstet Gynaecol India. 2022;72(2):141–6. DOI: https://doi.org/10.1007/s13224-021-01565-z

Giudice SD, Kao EA. Endometriosis: Pathogenesis, Diagnosis, and Treatment. Lancet. 2004;364(9447):1789–99. DOI: https://doi.org/10.1016/S0140-6736(04)17403-5

ESHRE Endometriosis Guideline Development Group. European Society of Human Reproduction and Embryology (ESHRE) Endometriosis Guideline. Hum Reprod. 2014;29(3):400–12. DOI: https://doi.org/10.1093/humrep/det457

Chapron MR, Fauconnier NK. Adenomyosis: Diagnosis and Management. Obstet Gynecol. 2004;104(4):832–9.

Robinson JA, Burke AE. Obesity and hormonal contraceptive efficacy. Womens Health (Lond). 2013;9(5):453–66. DOI: https://doi.org/10.2217/WHE.13.41

Westhoff CL, Torgal AH, Mayeda ER, Hoeger KM, Pike MC, Stanczyk FZ. Pharmacokinetics and ovarian suppression during use of a contraceptive vaginal ring in normal-weight and obese women. Am J Obstet Gynecol. 2012;207(1):391–6. DOI: https://doi.org/10.1016/j.ajog.2012.04.022

Muzii L, Di Tucci C, Galati G, Carbone F, Palaia I, Bogani G, et al. The Efficacy of Dienogest in Reducing Disease and Pain Recurrence after Endometriosis Surgery: a Systematic Review and Meta-Analysis. Reprod Sci. 2023;30(11):3135–43.

Andres Mde P, Lopes LA, Baracat EC, Podgaec S. Dienogest in the treatment of endometriosis: systematic review. Arch Gynecol Obstet. 2015;292(3):523–9. DOI: https://doi.org/10.1007/s00404-015-3681-6

Lin SC, Wang XY, Fu XL, Yang WH, Wu H, Bai Y, et al. Systematic review and meta-analysis of efficacy and safety of dienogest in treatment of endometriosis. World J Meta-Anal. 2021;9(4):377–88. DOI: https://doi.org/10.13105/wjma.v9.i4.377

Murji A, Biberoğlu K, Leng J, Mueller MD, Römer T, Vignali M, et al. Use of dienogest in endometriosis: a narrative literature review and expert commentary. Curr Med Res Opin. 2020;36(5):895–907. DOI: https://doi.org/10.1080/03007995.2020.1744120

La Torre F, Vannuccini S, Toscano F, Gallucci E, Orlandi G, Manzi V, et al. Long-term treatment for endometriosis with dienogest: efficacy, side effects and tolerability. Gynecol Endocrinol. 2024;40(1):56. DOI: https://doi.org/10.1080/09513590.2024.2336121

Maiorana A, Maranto M, Restivo V, Messina G, Tumminello G, Giaimo M, et al. Evaluation of long-term efficacy and safety of dienogest in patients with chronic cyclic pelvic pain associated with endometriosis. Arch Gynecol Obstet. 2024;309:589–97. DOI: https://doi.org/10.1007/s00404-023-07271-7

Muzii L, Di Tucci C, Galati G, Carbone F, Palaia I, Bogani G, et al. The efficacy of dienogest in reducing disease and pain recurrence after endometriosis surgery: a systematic review and meta-analysis. Reprod Sci. 2023;30:3135–43. DOI: https://doi.org/10.1007/s43032-023-01266-0

Li RR, Xi Q, Tao L, Zhang P, Huang Y, Liu F, et al. A systematic review and Bayesian analysis of the adverse effects of dienogest. BMC Pharmacol Toxicol. 2024;25:43. DOI: https://doi.org/10.1186/s40360-024-00767-1

Tang M, Yang W, Zhang H. Comparison of the efficacy of dienogest and GnRH-an after-endometriosis surgery. BMC Women Health. 2023;23:85. DOI: https://doi.org/10.1186/s12905-022-02118-w

Zakhari A, Edwards D, Ryu M, Matelski JJ, Bougie O, Murji A. Dienogest and the risk of endometriosis recurrence following surgery: a systematic review and meta-analysis. J Minim Invasive Gynecol. 2020;27(7):1503–10. DOI: https://doi.org/10.1016/j.jmig.2020.05.007

Wadden TA, Tronieri JS, Butryn ML. Lifestyle modification approaches for the treatment of obesity in adults. Am Psychol. 2020;75(2):235–51. DOI: https://doi.org/10.1037/amp0000517

Lv N, Azar KMJ, Rosas LG, Wulfovich S, Xiao L, Ma J. Behavioral lifestyle interventions for moderate and severe obesity: a systematic review. Prev Med. 2017;100:180–93. DOI: https://doi.org/10.1016/j.ypmed.2017.04.022

Wilson K. Obesity: Lifestyle Modification and Behavior Interventions. FP Essent. 2020;492:19–24.

Murphy E, Finucane FM. Structured lifestyle modification as an adjunct to obesity pharmacotherapy: there is much to learn. Int J Obes. 2024;3:563. DOI: https://doi.org/10.1038/s41366-024-01499-2

Bradley T, Campbell E, Dray J, O’Neil A, Berk M, Castle D, et al. Systematic review of lifestyle interventions to improve weight, physical activity and diet among people with a mental health condition. Syst Rev. 2022;11:198. DOI: https://doi.org/10.1186/s13643-022-02067-3

Liu R, Figueroa R, Brink HV, Zheng X, Herrera N, Li M, et al. The efficacy of sleep lifestyle interventions for the management of overweight or obesity in children: a systematic review and meta-analysis. BMC Public Health. 2024;24:321. DOI: https://doi.org/10.1186/s12889-024-17708-6

Finn EB, Whang C, Hong PH, Costa SA, Callahan EA, Huang TT. Strategies to improve the implementation of intensive lifestyle interventions for obesity. Front Public Health. 2023;11:1202545. DOI: https://doi.org/10.3389/fpubh.2023.1202545

Rotunda W, Rains C, Jacobs SR, Miller B, Green A, Patel K, et al. Weight loss in short-term interventions for physical activity and nutrition among adults with overweight or obesity: a systematic review and meta-analysis. Prev Chronic Dis. 2024;2:21. DOI: https://doi.org/10.5888/pcd21.230347

Downloads

Published

2025-05-29

How to Cite

Manickavasagam, M. M., Ramalakshmi, M., & Jeyajanani, R. (2025). Evaluation of the efficacy and tolerability of 4 mg dienogest in women with adenomyosis and BMI >30. International Journal of Reproduction, Contraception, Obstetrics and Gynecology, 14(6), 1783–1788. https://doi.org/10.18203/2320-1770.ijrcog20251562

Issue

Section

Original Research Articles