Randomized Controlled Trial of Depot Leuprolide in Patients With Chronic Pelvic Pain and Clinically Suspected Endometriosis
Abstract
In Brief Objective To evaluate and compare the safety and efficacy of leuprolide versus placebo in managing chronic pelvic pain in women with clinically suspected endometriosis. Methods Women 18–45 years of age with moderate to severe pelvic pain of at least 6 months' duration underwent extensive, noninvasive diagnostic testing and laboratory evaluation, including pelvic ultrasound, complete blood count, determination of erythrocyte sedimentation rate, and endocervical cultures. Those with clinically suspected endometriosis were randomized to double-blind treatment for 3 months with depot leuprolide (3.75 mg/mo) or placebo. The accuracy of the clinical diagnosis of endometriosis was evaluated by posttreatment laparoscopy. Results Of 100 women randomized, 95 completed the study: 49 in the leuprolide group and 46 in the placebo group. Women in the leuprolide group had clinically and statistically significant (P ≤ .001) mean improvements from baseline after 12 weeks of therapy in all pain measures. These mean improvements were significantly greater (P ≤ .001) than those in the placebo group. At 12 weeks, mean decreases in physician-rated scores for dysmenorrhea, pelvic pain, and pelvic tenderness were 1.7, 1.0, and 0.8 points greater, respectively, in the leuprolide group than in the placebo group (on a four-point scale). Thirty-eight (78%) of 49 and 40 (87%) of 46 patients in the leuprolide and placebo groups, respectively, had laparoscopically confirmed endometriosis after 12 weeks of treatment. No women withdrew from the study because of adverse events. Conclusion Depot leuprolide was effective and safe for treating patients with chronic pelvic pain and clinically suspected endometriosis, confirming the potential of its empiric use in these patients. Depot leuprolide is effective in treating chronic pelvic pain in women with suspected endometriosis.
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In a randomised controlled trial designed to evaluate the efficacy of leuprolide against placebo in the management of chronic pelvic pain among women with clinically diagnosed endometriosis, post-treatment laparoscopy confirmed 78% and 87% of clinically diagnosed cases in the leuprolide and placebo groups, respectively.
“Second, in a randomised controlled trial designed to evaluate the efficacy of leuprolide against placebo in the management of chronic pelvic pain among women with clinically diagnosed endometriosis, post-treatment laparoscopy confirmed 78% and 87% of clinically diagnosed cases in the leuprolide and placebo groups, respectively. 41”
From Risk of cardiovascular outcomes among women with endometriosis in the United Kingdom: a retrospective matched cohort study (2021) · cites this paper as [41]
Cites
Chronic Pelvic Pain: Prevalence, Health-Related Quality of Life, and Economic Correlates
Mathias, S. (1996) · Obstetrics & Gynecology · doi:10.1016/0029-7844(95)00458-0 · Cited by 1,074 · see citing works
Koninckx, P. R., Meuleman, C., Demeyere, S., Lesaffre, E., & Cornillie, F. J. (1991) · Fertility and Sterility · doi:10.1016/s0015-0282(16)54244-7 · Cited by 849 · see citing works
Sutton, C. J. G., Ewen, S. P., Whitelaw, N., & Haines, P. (1994) · Fertility and Sterility · doi:10.1016/s0015-0282(16)56990-8 · Cited by 525 · see citing works
The Role of Laparoscopy in Chronic Pelvic Pain: Promise and Pitfalls
HOWARD, F. M. (1993) · Obstetrical & Gynecological Survey · doi:10.1097/00006254-199306000-00001 · Cited by 434 · see citing works
Administration of Nasal Nafarelin as Compared with Oral Danazol for Endometriosis
Henzl, M. R., Corson, S. L., Moghissi, K. S., Buttram, V. C., Berqvist, C., & Jacobson, J. B. (1988) · New England Journal of Medicine · doi:10.1056/nejm198802253180805 · Cited by 359 · see citing works
Dlugi, A. M., Miller, J. D., & Knittle, J. (1990) · Fertility and Sterility · doi:10.1016/s0015-0282(16)53755-8 · Cited by 279 · see citing works
Balasch, J., Creus, M. T., Fábregues, F., Carmona, F., Ordï, J., Martínez‐Román, S., & Vanrell, J. A. (1996) · Human Reproduction · doi:10.1093/humrep/11.2.387 · Cited by 278 · see citing works
Dosage aspects of danazol therapy in endometriosis: Short-term and long-term effectiveness
Biberoglu, K. O., & Behrman, S. J. (1981) · American Journal of Obstetrics and Gynecology · doi:10.1016/0002-9378(81)90478-6 · Cited by 267 · see citing works
Gonadotropin-releasing hormone analogues for the treatment of endometriosis: long-term follow-up
Waller, K. G., & Shaw, R. W. (1993) · Fertility and Sterility · doi:10.1016/s0015-0282(16)55791-4 · Cited by 249 · see citing works
Sutton, C. J. G., Pooley, A. S., Ewen, S. P., & Haines, P. (1997) · Fertility and Sterility · doi:10.1016/s0015-0282(97)00403-2 · Cited by 247 · see citing works
Combined hysteroscopic and laparoscopic findings in patients with chronic pelvic pain
Carter, J. E. (1994) · The Journal of the American Association of Gynecologic Laparoscopists · doi:10.1016/s1074-3804(05)80830-8 · Cited by 175 · see citing works
A Profile of Women with Chronic Pelvic Pain
Relter, R. C. (1990) · Clinical Obstetrics & Gynecology · doi:10.1097/00003081-199003000-00018 · Cited by 146 · see citing works
Use of nafarelin versus placebo after reductive laparoscopic surgery for endometriosis
Hornstein, M. D., Hemmings, R., Yuzpe, A. A., & Heinrichs, W. L. (1997) · Fertility and Sterility · doi:10.1016/s0015-0282(97)00360-9 · Cited by 145 · see citing works
A Psychosomatic Study of Pelvic Congestion
Duncan, C. H., & Taylor, H. C. (1952) · American Journal of Obstetrics and Gynecology · doi:10.1016/s0002-9378(16)38730-0 · Cited by 119 · see citing works
McQuay, H., Carroll, D., & Moore, A. R. (1996) · Pain · doi:10.1016/0304-3959(95)00116-6 · Cited by 118 · see citing works
Depot leuprolide versus danazol in treatment of women with symptomatic endometriosis
Wheeler, J. M., Knittle, J. D., & Miller, J. D. (1992) · American Journal of Obstetrics and Gynecology · doi:10.1016/s0002-9378(11)91718-9 · Cited by 106 · see citing works
Steege, J. F., Stout, A. L., & Somkuti, S. G. (1993) · Obstetrical & Gynecological Survey · doi:10.1097/00006254-199302000-00014 · Cited by 73 · see citing works
Dynamics and significance of placebo response in primary dysmenorrhea
Fedele, L., Marchini, M., Acaia, B., Garagiola, U., & Tiengo, M. (1989) · Pain · doi:10.1016/0304-3959(89)90110-3 · Cited by 66 · see citing works
Mathias, J. R., Clench, M. H., Abell, T. L., Koch, K. L., Lehman, G. A., ROBINSON, M. G., Rothstein, R. D., & Snape, W. J. (1998) · Digestive Diseases and Sciences · doi:10.1023/a:1018888631286 · Cited by 63 · see citing works
Nolan, T. E., & Elkins, T. E. (1993) · Postgraduate Medicine · doi:10.1080/00325481.1993.11945774 · Cited by 20 · see citing works
Surgical Treatment of Minimal Endometriosis
Gambone, J. C., & DeCherney, A. H. (1997) · New England Journal of Medicine · doi:10.1056/nejm199707243370409 · Cited by 13 · see citing works
A card sort method for pain assessment in gynaecology: A multidimensional approach
Reading, A. E., Reed, C., & Newton, J. R. (1979) · Acta Obstetricia Et Gynecologica Scandinavica · doi:10.3109/00016347909154925 · Cited by 9 · see citing works
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Sinaii, N., Cleary, S. D., Younes, N., Ballweg, M. L., & Stratton, P. (2007) · Fertility and Sterility · doi:10.1016/j.fertnstert.2006.11.051 · Cited by 96 · see citing works
Okoth, K., Wang, J., Zemedikun, D., Thomas, G., Nirantharakumar, K., & Adderley, N. (2021) · BJOG: An International Journal of Obstetrics & Gynaecology · doi:10.1111/1471-0528.16692 · Cited by 88 · see citing works
- Authors
- LING, F. W.
- Affiliations
- University of Tennessee Health Science Center (US)
- Corresponding author
- LING, FRANK W.
- Venue
- Obstetrics & Gynecology
- Published
- 1999-01
- Volume
- 93
- Issue
- 1
- Pages
- 51-58
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W2145262010
- Cited by
- 223
- References
- 22
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 1 · 2023: 2 · 2022: 4 · 2021: 6 · 2020: 8 · 2019: 4 · 2018: 8 · 2017: 4 · 2016: 7 · 2015: 10 · 2014: 13 · 2013: 11 · 2012: 13
- FWCI
- 6.78
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Endometriosis Research and Treatment
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ectopic Pregnancy Diagnosis and Management
- Health Sciences › Medicine › Obstetrics and Gynecology › Gynecological conditions and treatments
- Keywords
- chronic pelvic pain, endometriosis, dysmenorrhea, GnRH agonist therapy, laparoscopic confirmation
- MeSH terms
- Adolescent, Adult, Algorithms, Chronic Disease, Delayed-Action Preparations, Double-Blind Method, Endometriosis, Female, Humans, Middle Aged, Laparoscopy, Leuprolide, Pelvic Pain
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