An open randomized comparative study of the effect of goserelin depot and danazol in the treatment of endometriosis
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Objective To compare the efficacy and safety of goserelin depot and danazol for endometriosis. Design Open, randomized comparative trial. Setting Multicenter European academic clinical institutions. Patients A total of 307 patients with laparoscopically diagnosed endometriosis were randomized to goserelin (n = 204) or danazol (n = 103); 249 patients underwent second look laparoscopy (175 received goserelin and 74 danazol) and were analyzed for efficacy. Interventions A 3.6-mg depot of goserelin monthly subcutaneously or oral danazol 200 mg three times a day administered for 24 weeks. Main outcome measures Efficacy assessments were based on changes in visible deposits at laparoscopy before and after treatment and subjective symptom scores at 4-week intervals during treatment and 8-week intervals after treatment for up to 24 weeks. Safety was assessed by adverse event reporting and clinical laboratory measures. Results There were similar proportions of symptomatic (73%) and asymptomatic (but infertile) (27%) and comparable distribution of different severity of endometriosis randomized to each treatment. Significantly fewer patients randomized to goserelin (6.4%) withdrew during treatment compared with 20.4% randomized to danazol (P less than 0.05). There were significantly reduced visible deposits of endometriosis found post-treatment (P less than 0.0001) within each group but no differences between the treatments. The mean total subjective symptoms scores remained significantly less than entry at 24 weeks post-treatment (P less than 0.05). Hypoestrogenic side effects were more common in those receiving goserelin, particularly hot flushes, but anabolic/androgenic side effects of weight gain and muscle cramps were more common in those receiving danazol. Conclusions The monthly administered 3.6-mg depot preparation of goserelin was highly effective at inducing resolution of endometriotic implants and relieving the symptoms of endometriosis with prevention of their return during 24 weeks follow-up in the majority of patients. However, results were not significantly different from those achieved with danazol 600 mg/d.
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Change in endometriosis score has been used to assess treatment effect under the assumption, unsupported by evidence, that lesion score correlates with pain score.
“Third, change in endometriosis score has been used to assess treatment effect with the assumption, but no evidence, that lesion score correlates with pain score”
From Chronic pelvic pain and endometriosis: translational evidence of the relationship and implications (2011) · cites this paper as Shaw, 1992
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- Authors
- Shaw, R. W.
- Affiliations
- The Royal Free Hospital (GB)
- Corresponding author
- Shaw, Robert W.
- Venue
- Fertility and Sterility
- Publisher
- Elsevier BV
- Published
- 1992-08
- Volume
- 58
- Issue
- 2
- Pages
- 265-272
- ISSN
- 0015-0282 (ISSN-L)
- OpenAlex
- W2417044776
- Cited by
- 119
- References
- 18
- Citations by year
- 2026: 3 · 2024: 1 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 2 · 2018: 1 · 2017: 2 · 2016: 2 · 2014: 1 · 2013: 1 · 2012: 2
- FWCI
- 8.13
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Fertility and Sterility (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 › Endometrial and Cervical Cancer Treatments
- Keywords
- endometriosis, danazol, GnRH agonist therapy, symptom scores, treatment efficacy, treatment safety, androgenic side effects, weight gain, infertility
- MeSH terms
- Adolescent, Adult, Buserelin, Danazol, Delayed-Action Preparations, Endometriosis, Female, Humans, Menstruation, Pregnancy, Goserelin
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