Assessment of safety

Depot leuprolide acetate and danazol seem to have similar side effects and similar effectiveness in the treatment of symptomatic endometriosis. The endometrium is the tissue that lines the uterus. Growth of this tissue outside the uterus is known as endometriosis. Women were randomly assigned to be treated for 24 weeks with either danazol or leuprolide acetate. One hundred thirty-four women received monthly injections of leuprolide and 136 took daily doses of danazol orally. The most significant side effect of leuprolide acetate was a loss of bone mineral density. Early evidence suggests that this decrease can be reversed after discontinuation of treatment, but further research is needed. The most significant side effect associated with danazol was that levels of high-density lipoproteins were lowered, sometimes below the normal range. These effects may also be reversible, but again, further study is needed. Other side effects, such as hot flushes and acne, were reported by 94% of the leuprolide patients and 90% of the danazol group. Few women withdrew from the study or complained of severe side effects.