Randomized Controlled Trial of Depot Leuprolide in Patients With Chronic Pelvic Pain and Clinically Suspected Endometriosis

Frank W. Ling
In: Obstetrics & Gynecology · 1999 · vol. 93(1) , pp. 51–58 · doi:10.1097/00006250-199901000-00012 · W4233181394
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Depot leuprolide significantly improved pain measures in women with suspected endometriosis compared to placebo, demonstrating safety and efficacy for empiric use.

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This randomized controlled trial evaluated the safety and efficacy of depot leuprolide compared to placebo for managing chronic pelvic pain in women with clinically suspected endometriosis. The study included 100 women aged 18–45 who underwent extensive noninvasive diagnostic testing before being assigned to receive either monthly leuprolide injections or a placebo for three months. Results indicated that patients treated with leuprolide experienced statistically significant improvements in dysmenorrhea, pelvic pain, and tenderness relative to the placebo group, with no withdrawals due to adverse events. Although laparoscopy confirmed endometriosis in the majority of participants regardless of treatment arm, the drug demonstrated clear symptomatic benefit for those with suspected disease. This paper is centrally about endometriosis — specifically evaluating medical management for patients with clinically suspected lesions presenting as chronic pelvic pain.

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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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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.

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Condition tags

endometriosischronic_pelvic_paindysmenorrhea

Citation neighborhood

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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