Medical treatment of endometriosis: a comparative trial. Buserelin versus danazol in the treatment of endometriosis-associated infertility. An open randomized comparative study of the effect of goserelin depot and danazol in the treatment of endometriosis. Zoladex Endometriosis Study Team. Depot leuprolide versus danazol in treatment of women with symptomatic endometriosis. I. Efficacy results. Placebo-controlled comparison of danazol and high-dose medroxyprogesterone acetate in the treatment of endometriosis. A randomized, prospective comparison of endocrine changes induced with intranasal leuprolide or danazol for treatment of endometriosis. A randomized, comparative trial of triptorelin depot (D-Trp6-LHRH) and danazol in the treatment of endometriosis. Zoladex (goserelin acetate implant) in the treatment of endometriosis: a randomized comparison with danazol. The Zoladex Endometriosis Study Group. [Medical treatment of endometriosis: comparative study of leuprolide acetate and danazol].
In a comparison of danazol, and mestranol with norethynodrel (Enavid, Searle) in the treatment of endometriosis danazol was shown to be superior. Danazol is however relatively ineffective when large tumours or extensive adhesions are present and such patients will usually need a surgical operation. Women who have completed their families and who have severe symptoms will be better treated by hysterectomy. Treatment with danazol is indicated for young women with mild or moderate endometriosis. Danazol treatment may also be given postoperatively after conservative operations. A total of 62 infertile women with a laparoscopic diagnosis of endometriosis were allocated randomly to two treatment groups, one of which (32 patients) received oral danazol 600 micrograms/day and the other (30 patients) received intranasal buserelin 1200 micrograms/day for 6 months. Suppression of serum levels of estradiol was greater with the gonadotropin-releasing hormone agonist treatment. Pain symptoms improved markedly during treatment in both groups. At the end of treatment a repeat laparoscopy was performed only in the patients who agreed to it (12 in the buserelin group and 13 in the danazol group), and it did not reveal significant differences in the effects of the two treatments on the endometriotic implants. All of the patients were followed up for at least 12 months, during which pregnancy was attempted. At 18 months the cumulative pregnancy rate was 48% in the patients treated with buserelin and 43% in those treated with danazol. Pain recurrence was observed in about half of the patients in each group 1 year after treatment suspension. The side effects were more frequent and more severe in the danazol-treated patients, whereas those given buserelin generally reported only symptoms of hypoestrogenism. The results of this study suggests that buserelin is at least as effective as danazol in the treatment of endometriosis when the outcome is considered in terms of restored fertility, and its side effects are less severe. To compare the efficacy and safety of goserelin depot and danazol for endometriosis.
                Open, randomized comparative trial.
                Multicenter European academic clinical institutions.
                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.
                A 3.6-mg depot of goserelin monthly subcutaneously or oral danazol 200 mg three times a day administered for 24 weeks.
                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.
                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.
                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. We aimed to assess the efficacy of depot leuprolide versus danazol in the treatment of endometriosis.
                A double-blind randomized trial of 270 patients from 22 centers compared the pretreatment and posttreatment laparoscopic extent of endometriosis. Pretreatment and posttreatment endometriosis symptoms and signs were assessed with standardized methods.
                When compared with danazol, leuprolide depot caused a more rapid and profound suppression of estradiol. Leuprolide depot and danazol were similarly efficacious in decreasing the extent of endometriosis, as well as the pain and tenderness associated with endometriosis.
                Depot leuprolide is an effective alternative to danazol in decreasing the extent of endometriosis and endometriosis-related pain. A prospective, double-blind, placebo-controlled study was designed to evaluate the clinical efficacy and tolerance of danazol and high-dose medroxyprogesterone acetate (MPA) in the treatment of mild-moderate endometriosis. After laparoscopical confirmation of endometriosis, 59 patients were randomized to receive danazol (200 mg 3 times daily), MPA (100 mg daily) or placebo for 6 months. Clinical examinations were done before and 1, 3, 6 and 12 months after the beginning of the study, and a 2nd laparoscopy 6 months after termination of the medication. Eighteen patients in the danazol group, 16 in the MPA group and 17 in the placebo group completed the trial. Total or partial resolution of peritoneal implants was observed in 60% of the patients receiving danazol and in 63% of the patients receiving MPA. In the placebo group, resolution was observed in 18%, while the size of the implants was estimated to be increased in 23% of the patients. In relation to placebo, danazol and MPA significantly alleviated endometriosis-associated pelvic pain, lower back pain and defecation pain, but they did not differ from each other in these actions. The appearance of acne, muscle cramps, edema, weight gain and spotting bleeding complicated MPA treatment. The present results indicate that because of good efficacy and tolerance, high-dose MPA is a useful alternative in the hormonal treatment of endometriosis. A prospective, randomized trial compared hormonal changes induced with intranasal leuprolide 1.6 mg/day to danazol 800 mg/day for treatment of endometriosis. Both regimens induced anovulation and ovarian suppression in all subjects. Mean estradiol (E2) and progesterone (P) levels were suppressed with both regimens, but were lower with leuprolide. There was no difference in cumulative follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels, although at times during treatment mean levels of these hormones were lower with leuprolide. Higher P levels in the danazol group, most likely of adrenal origin, indicated a suppressive effect on adrenal steroidogenesis. Symptomatic improvement was significant in both groups. Laparoscopy after treatment also demonstrated a decrease in endometriosis scores in both groups. At 12 months after treatment, cumulative pregnancy and live birth rates were similar in both groups. Leuprolide offers an attractive alternative to danazol for the medical treatment of endometriosis. To compare treatment efficacy and safety parameters a total of 55 premenopausal women with histologically proven endometriosis (stage II-IV) were randomized to receive the LHRH-analogue depot triptorelin (n = 30) or the steroid danazol (n = 25) for a total of 24 weeks. Immediately after cessation of the endocrine therapy a second-look operation was performed. Four as well as 24 weeks after the end of treatment patients were seen for re-evaluation of clinical symptoms and safety parameters. Estradiol suppression was significantly more pronounced with triptorelin, while the free androgenic index rose with danazol. Both substances were equally effective in reducing endometriotic implants (58% and 51%, respectively). Dysmenorrhea was absent at the end of medical therapy in both treatment groups. Dyspareunia and pelvic pain decreased at least by 50%. Red blood count, thrombocytes, liver enzymes and the atherogenic index rose with danazol, while the urinary calcium/creatinine ratio showed a marked elevation with triptorelin. Adverse effects were mainly due to the hypoestrogenism of the LHRH analogue and the androgenic/anabolic properties of the steroid. Triptorelin and danazol are equally effective in treating endometriosis. Therefore, choice of treatment should be based on the patient's medical history and the pharmacological profile of each substance. To compare the efficacy, endocrine effects, and safety of Zoladex (goserelin acetate) and danazol in the treatment of premenopausal women with endometriosis in a multicenter, randomized, open study.
                Three hundred fifteen patients with stages I-IV endometriosis (revised American Fertility Society [AFS] classification) were treated with Zoladex, 3.6 mg every 28 days by subcutaneous injection, or danazol, 400 mg orally twice daily for 24 weeks. Efficacy was assessed by determination of pelvic signs and symptoms scores and revised AFS endometriosis scores. Endocrine effects were determined by measurements of hormone levels. Safety was evaluated by physical examination, laboratory indices, occurrence of adverse events, and bone mineral density changes.
                Both treatments significantly (P < .0001) reduced mean subjective signs and symptoms scores both during and after therapy. The mean percent reduction in the revised AFS endometriosis score after 24 weeks of treatment was 53% for Zoladex and 33% for danazol, and reduction in the endometrial implants score was 56% for Zoladex and 46% for danazol. Serum estradiol levels decreased to the postmenopausal range in the Zoladex group and to the early follicular phase range in the danazol group. Hypoestrogenic effects occurred more frequently with Zoladex, whereas androgenic side effects were more common with danazol. There was a higher percentage of withdrawals due to adverse events with danazol than with Zoladex. Mean bone mineral density decreased from baseline by 5.4% in the Zoladex group and increased by 1.0% in the danazol group at the end of treatment.
                Zoladex is as well tolerated and as effective as danazol in the treatment of premenopausal women with endometriosis. Hypo-oestrogenaemia following surgical oophorectomy leads to a regression of the ectopic endometrial tissue. A medical and transitory oophorectomy can be obtained using leuprolide ac., an analogue of LH-RH. In this study we compare the results of therapy with danazol or leuprolide in the treatment of endometriosis. Fifty patients affected by endometriosis were selected laparoscopically and recorded under the classification of American Fertility Society. 20-40 year old women who were admitted had not received any therapy for endometriosis within the previous 12 months. They were allocated at random to open treatment with intramuscular injection of leuprolide (3.75 mg/monthly) or oral danazol. The dose regimen used for this last drug was 600 mg/daily in the majority of patients. 47 women completed a six months therapy, and 42 underwent to a second laparoscopy to evaluate the effects of the treatment. Both danazol and leuprolide were associated to a decreasing of clinical symptoms and to adverse effects that we described in this paper.
Danazol is effective in treating the symptoms and signs of endometriosis. However, its use is limited by the occurrence of androgenic side effects.