Randomized clinical trial of a levonorgestrel-releasing intrauterine system and a depot GnRH analogue for the treatment of chronic pelvic pain in women with endometriosis
Abstract
BACKGROUND: The objective of this multicentre randomized, controlled clinical trial was to compare the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) and a depot-GnRH-analogue in the control of endometriosis-related pain over a period of six months. METHODS: Eighty-two women, 18 to 40 years of age (mean 30 years), with endometriosis, dysmenorrhoea and/or CPP, were randomized using a computer-generated system of sealed envelopes into either LNG-IUS (n = 39) or GnRH analogue (n = 43) treatment groups at three university centres. Daily scores of endometriosis-associated CPP were evaluated using the Visual Analogue Scale (VAS), daily bleeding score was calculated from bleeding calendars, and improvement in quality of life was evaluated using the Psychological General Well-Being Index Questionnaire (PGWBI). The pain score diary was based on the VAS in which women recorded the occurrence and intensity of pain on a daily basis. A monthly score was calculated from the result of the sum of the daily scores divided by the number of days in each observation period. RESULTS: CPP decreased significantly from the first month throughout the six months of therapy with both forms of treatment and there was no difference between the groups (P > 0.999). In both treatment groups, women with stage III and IV endometriosis showed a more rapid improvement in the VAS pain score than women with stage I and II of the disease (P < 0.002). LNG-IUS users had a higher bleeding score than GnRH-analogue users at all time points of observation with 34% and 71% of patients in the LNG-IUS and GnRH-analogue groups, respectively, reporting no bleeding during the first treatment month, and 70% and 98% reporting no bleeding during the sixth month. No difference was observed between groups with reference to improvement in quality of life. CONCLUSIONS: Both, the LNG-IUS and the GnRH-analogue were effective in the treatment of CPP-associated endometriosis, although no differences were observed between the two treatments. Among the additional advantages of the LNG-IUS is the fact that it does not provoke hypoestrogenism and that it requires only one medical intervention for its introduction every 5 years. This device could therefore become the treatment of choice for CPP-associated endometriosis in women who do not wish to conceive.
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In that trial, 13% (n=5) of LNG-IUS patients and 14% (n=6) of GnRHa patients failed to reach a VAS pain score of less than three.
“At the end of the study, the 13% ( n = 5) of patients in the LNG-IUS group and the 14% ( n = 6) in the GnRHa group failed to reach a VAS pain score of less than three.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [80]
In both treatment groups of that trial, patients with stage III and IV disease achieved the more rapid improvement in VAS score.
“In both treatment groups, the subgroup of patients that achieved the more rapid improvement in VAS score was the one of patients with stage III and IV of the disease.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [80]
In a Brazilian multicenter trial of 82 women with symptomatic endometriosis, LNG-IUS and depot GnRHa were similarly effective at 6 months for endometriosis-related chronic pelvic pain, with a six-point decrease from baseline in VAS pain score in both groups.
“In particular, a Brazilian multicenter trial [80] compared the efficacy of the LNG-IUS and a depot GnRHa in 82 women with symptomatic endometriosis. At 6-months follow-up both treatments appeared to be similarly effective for endometriosis-related chronic pelvic pain, with a six-points decrease from baseline in VAS pain score in both study groups.”
From Oral and depot progestin therapy for endometriosis: towards a personalized medicine (2017) · cites this paper as [80]
Progestins are positively associated with health-related quality of life in women with endometriosis.
“Progestins were positively associated with HRQoL in women with endometriosis [20,21,23-25,27,29,30].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [23]
Six months of progestin therapy is equivalent to GnRHa in improving health-related quality of life and reducing pain in women with endometriosis.
“Moreover, six months of therapy with progestins seemed equivalent to that of GnRHa in improving HRQoL and reducing pain, according to six RCTs [20,23-25,27,29].”
From Health-related quality of life in women with endometriosis: a systematic review (2012) · cites this paper as [23]
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- Authors
- Petta, C. A., Ferriani, R. A., Abrao, M. S., Hassan, D., Rosa e Silva, J. C., Podgaec, S., & Bahamondes, L.
- Affiliations
- Universidade Estadual de Campinas (UNICAMP) (BR)
- Corresponding author
- Petta, Carlos A.
- Venue
- Human Reproduction
- Publisher
- Oxford University Press (OUP)
- Published
- 2005-03-24
- Volume
- 20
- Issue
- 7
- Pages
- 1993-1998
- ISSN
- 0268-1161 (ISSN-L)
- 1460-2350
- OpenAlex
- W2123134517
- Cited by
- 363
- References
- 34
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 5 · 2023: 5 · 2022: 22 · 2021: 16 · 2020: 12 · 2019: 12 · 2018: 18 · 2017: 16 · 2016: 19 · 2015: 22 · 2014: 20 · 2013: 17 · 2012: 19
- FWCI
- 25.58
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Human Reproduction (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Menstrual Health and Disorders
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ectopic Pregnancy Diagnosis and Management
- Keywords
- endometriosis, chronic pelvic pain, levonorgestrel-releasing intrauterine system, dysmenorrhea, endometriosis-associated pain, hemorrhage, quality of life, endometriosis stage, estrogen deficiency, treatment efficacy comparison, psychological well-being
- MeSH terms
- Adolescent, Adult, Delayed-Action Preparations, Endometriosis, Female, Humans, Intrauterine Devices, Medicated, Gonadotropin-Releasing Hormone, Leuprolide, Levonorgestrel, Pelvic Pain
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