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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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“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 the citing paper
“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 the citing paper
“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]
In the citing paper
“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]
In the citing paper
“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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Influential“Waiting for Godot”: a commonsense approach to the medical treatment of endometriosis
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“Studies have shown that the progestin-only contraceptives injectable DMPA [92], LNGIUS [93], and etonogestrel subdermal implant [94] improve endometriosis symptoms.”
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“A patient questionnaire showed marked improvement with both treatments in QoL and health-related satisfaction scores compared with preoperative values; no significant differences were found between the groups.”
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Prentice, A., Deary, A., Goldbeck-Wood, S., Farquhar, C., & Smith, S. (1999) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd000346 · Cited by 116
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“endometriosis had a faster amelioration in pain scores than those with stage I and II [60].”
BackgroundJensen, J. T. (2009) · International Journal of Women s Health · doi:10.2147/ijwh.s4350 · Cited by 69
Hidalgo, M. M., Hidalgo-Regina, C., Bahamondes, M. V., MONTEIRO, I. M. U., Petta, C. A., & Bahamondes, L. G. (2009) · Contraception · doi:10.1016/j.contraception.2009.01.004 · Cited by 67
“In addition, this device has been used off-label as a treatment for endometriosis [8,9] and for endometrial hyperplasia [10,11].”
MethodSelf-citationPharmacological Treatment of Endometriosis
Ferrero, S., Venturini, P. L., Ragni, N., Camerini, G. B., & Remorgida, V. (2009) · Drugs · doi:10.2165/00003495-200969080-00001 · Cited by 64
New trends of progestins treatment of endometriosis
Angioni, S. L., Cofelice, V., Pontis, A., Tinelli, R., & Socolov, R. V. (2014) · Gynecological Endocrinology · doi:10.3109/09513590.2014.950646 · Cited by 60
Current pharmacotherapy for endometriosis
Ferrero, S., Remorgida, V., & Venturini, P. L. (2010) · Expert Opinion on Pharmacotherapy · doi:10.1517/14656561003685880 · Cited by 60
“A prospective non-comparative observational study including 34 women with endometriosis demonstrated that the use of the Lng-IUD for 6 months significantly reduces not only pain and menstrual symptoms but also the extent of the disease observed at second-look laparoscopy [41].”
BackgroundInfluentialOral and depot progestin therapy for endometriosis: towards a personalized medicine
Buggio, L., Somigliana, E., Barbara, G., Frattaruolo, M. P., & Vercellini, P. (2017) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2017.1381086 · Cited by 58
“In particular, a Brazilian multicenter trial [80] compared the efficacy of the LNG-IUS and a depot GnRHa in 82 women with symptomatic endometriosis.”
BackgroundEndometriosis: The way forward
Hompes, P. G. A., & Mijatovic, V. (2007) · Gynecological Endocrinology · doi:10.1080/09513590601010474 · Cited by 55
“The second trial [51] compared the efficacy of an LNG-IUD and a GnRH-agonist analog in the control of chronic pelvic pain in 83 women with stage I–IV endometriosis during a period of 6 months.”
BackgroundFerreira, R. A., Vieira, C. S., Silva, J. C. R. E., Rosa-e-Silva, A. C. J. S., Nogueira, A. A., & Ferriani, R. A. (2009) · Contraception · doi:10.1016/j.contraception.2009.08.003 · Cited by 55
“Thus, treatment with the LNG-IUS may have metabolic advantages in addition to patient's acceptance and compliance with its prolonged use, as previously reported [16,29].”
InfluentialSelf-citationGomes, M. K. O., Rosa-e-Silva, J. C., Garcia, S. B., de Sa Rosa-e-Silva, A. C. J., Turatti, A., Vieira, C. S., & Ferriani, R. A. (2009) · Human Reproduction · doi:10.1093/humrep/dep288 · Cited by 54
“These findings explain at least part of the mechanism of the clinical improvement (Vercellini et al., 2003; Lockhat et al., 2005; Petta et al., 2005) and absence of worsening of laparoscopic staging (Gomes et al., 2007) observed in endometriosis patients using the LNG-IUS.”
InfluentialSelf-citationCurrent Strategies for Endometriosis Management
Kodaman, P. H. (2015) · Obstetrics and Gynecology Clinics of North America · doi:10.1016/j.ogc.2014.10.005 · Cited by 54
Yoost, J. (2014) · Patient Preference and Adherence · doi:10.2147/ppa.s45710 · Cited by 51
“68 Recent studies have randomized women with endo-metriosis to either LNG-20 IUD or gonadotropin-releasing hormone agonists (GnRHa), 69,70 or expectant management postoperatively.”
New developments in intrauterine device use: focus on the US
Nelson, A. L., & Massoudi, N. (2016) · Open Access Journal of Contraception · doi:10.2147/oajc.s85755 · Cited by 55
Endometriosis: Diagnosis and Management
Leyland, N. A., Casper, R. F., Laberge, P. Y., Singh, S. S., Allen, L. M., Arendas, K., Leyland, N. A., Allaire, C., Awadalla, A., Best, C., et al. (2010) · Journal of Endometriosis and Pelvic Pain Disorders · doi:10.1177/228402651000200303 · Cited by 52
Management of Chronic Pelvic Pain
Shin, J. H., & Howard, F. M. (2011) · Current Pain and Headache Reports · doi:10.1007/s11916-011-0204-4 · Cited by 50
Progestin Therapy in Endometriosis
Gezer, A., & Oral, E. (2015) · Women s Health · doi:10.2217/whe.15.42 · Cited by 50
de Sá Rosa e Silva, A. C. J., Rosa e Silva, J. C., Nogueira, A. A., Petta, C. A., Abrão, M. S., & Ferriani, R. A. (2006) · Fertility and Sterility · doi:10.1016/j.fertnstert.2006.02.082 · Cited by 46
Self-citationIntrauterine devices and adolescents
Gold, M. A., & Johnson, L. M. (2008) · Current Opinion in Obstetrics & Gynecology · doi:10.1097/gco.0b013e32830a98f8 · Cited by 47
Pashov, P. A. I., Tskhay, V. B., & Ionouchene, S. V. (2012) · Gynecological Endocrinology · doi:10.3109/09513590.2011.649813 · Cited by 47
On-label and off-label drug use in the treatment of endometriosis
Quaas, A. M., Weedin, E. A., & Hansen, K. R. (2015) · Fertility and Sterility · doi:10.1016/j.fertnstert.2015.01.006 · Cited by 45
Mindfulness‐based program for stress reduction in infertile women: Randomized controlled trial
Nery, S. F., Paiva, S. P. C., Vieira, É. L., Barbosa, A. B., Sant'Anna, E. M., Casalechi, M., Dela Cruz, C., Teixeira, A. L., & Reis, F. M. (2019) · Stress and Health · doi:10.1002/smi.2839 · Cited by 50
Emerging indications for the levonorgestrel‐releasing intrauterine system (LNG‐IUS)
Heikinheimo, O., & Gemzell‐Danielsson, K. (2011) · Acta Obstetricia Et Gynecologica Scandinavica · doi:10.1111/j.1600-0412.2011.01303.x · Cited by 46
“As with a GnRH analogue, a rapid therapeutic effect of the LNG-IUS is seen among those responding to the therapies (18).”
BackgroundBahamondes, L. G., Espejo‐Arce, X., Hidalgo, M. M., Hidalgo-Regina, C., Juliato, C. R. T., & Petta, C. A. (2005) · Human Reproduction · doi:10.1093/humrep/dei457 · Cited by 46
“This is one of the non-contraceptive benefits of the LNG-IUS and permits its use in menorrhagic patients as an alternative to hysterectomy (Monteiro et al ., 2002; Hurskainen et al ., 2004) and in women suffering from endometriosis-related pain (Lockhat et al ., 2005; Petta et al ., 2005).”
BackgroundSelf-citationAnalysis of the levonorgestrel-releasing intrauterine system in women with endometriosis
Shen, L., Ling, L., Jianhong, Z., Jiang, X., & Lihui, W. (2013) · Journal of International Medical Research · doi:10.1177/0300060513479865 · Cited by 46
Clinical applications of levonorgestrel-releasing intrauterine system to gynecologic diseases
Kim, M., & Seong, S. J. (2013) · Obstetrics & Gynecology Science · doi:10.5468/ogs.2013.56.2.67 · Cited by 45
Fraser, I. S. (2012) · Contraception · doi:10.1016/j.contraception.2012.08.039 · Cited by 44
Chronic pelvic pain in women: still a challenge
Dalpiaz, O., Kerschbaumer, A., Mitterberger, M., Pinggera, G., Bartsch, G. C., & Strasser, H. (2008) · British Journal of Urology · doi:10.1111/j.1464-410x.2008.07771.x · Cited by 45
Long-term use of the levonorgestrel-releasing intrauterine system
Inki, P. (2007) · Contraception · doi:10.1016/j.contraception.2006.12.016 · Cited by 45
“Two RCTs are available, one compared LNG IUS use with observation [36] and the other compared it with gonadotropin-releasing hormone analogue [37].”
BackgroundAbou-Setta, A. M., Al-Inany, H. G., & Farquhar, C. M. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005072.pub2 · Cited by 45
Samy, A., Taher, A. M., Sileem, S., Abdelhakim, A. M., Fathi, M. M., Haggag, H. M., Ashour, K., Ahmed, S. A., Shareef, M. A., AlAmodi, A. A., et al. (2020) · Journal of Gynecology Obstetrics and Human Reproduction · doi:10.1016/j.jogoh.2020.101798 · Cited by 44
Use of Levonorgestrel Intrauterine System for Medical Indications in Adolescents
Bayer, L. L., & Hillard, P. J. A. (2013) · Journal of Adolescent Health · doi:10.1016/j.jadohealth.2012.09.022 · Cited by 42
“comparing LNG-IUS with a depot gonadotropin-releasing hormone (GnRH) analogue that showed comparable reductions in pelvic pain and improved quality of life measures at 6 months, with 58% of women still using LNG-IUS at 36months [55,56].”
BackgroundPrise en charge d'une endométriose douloureuse
Roman, H. (2007) · Journal de gynécologie, obstétrique et biologie de la reproduction. Supplément/Journal de gynécologie obstétrique et biologie de la reproduction · doi:10.1016/j.jgyn.2006.12.008 · Cited by 42
Tolerability considerations for gonadotropin-releasing hormone analogues for endometriosis
Corte, L. D., Barra, F., Mercorio, A., Evangelisti, G., Rapisarda, A. M. C., Ferrero, S., Bifulco, G., & Giampaolino, P. (2020) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2020.1789591 · Cited by 44
The levonorgestrel-releasing intrauterine system and endometriosis staging
Gomes, M. K. O., Ferriani, R. A., Silva, J. C. R. E., Silva, A. C. J. D. S. R. E., Vieira, C. S., & dos Reis, F. J. C. (2007) · Fertility and Sterility · doi:10.1016/j.fertnstert.2006.11.044 · Cited by 43
Self-citationLevonorgestrel intrauterine system: bleeding disorders and anticoagulant therapy
Kadir, R. A., & Chi, C. (2007) · Contraception · doi:10.1016/j.contraception.2007.01.005 · Cited by 43
“The LNG-IUS has been shown to be associated with a reduction in menstrual pain and severity of the disease in women with endometriosis [25,29,30].”
BackgroundEvidence-based management of endometrioma
Gelbaya, T. A., & Nardo, L. G. (2011) · Reproductive BioMedicine Online · doi:10.1016/j.rbmo.2010.11.013 · Cited by 42
“Although there is some evidence to suggest that untreated endometriosis may resolve spontaneously in up to a third of women (Petta et al., 2005; Vercellini et al., 2003), the natural course of endometrioma is unknown.”
Background
Metadata
- 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 › Obstetrics and Gynecology › 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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