Prospective, randomized study on the efficacy and safety of the 1M-and 3M-depot of leuprorelinacetate in patients with uterine fibroids

Purpose: To evaluate whether a 3M-depot of leuprorelinacetate injected ever y 3 months is comparable in regard to efficacy and the side-effect profile to the I M-depot of leuprorelinacetate which is longtime established as pre operative treatment in uterine fibroids. Methods: In a prospective randomized study 28 patients (141M-depot and 14 3 M-depot) with sonographically confirmed uterine fibroids were enrolled. 27 of these patients were eligible. The patients had two injections of the 3M- or 6 injections of the I M-depot with 11.25 or 3.75 mg leuprorelinacetate respectively. The volume of the fibroids and the uterus were compared to ba seline after 3 and 6 months of treatment. Clinical symptoms were judged acc ording to Biberoglu and Behrmann [3]. Side-effects were compared. Results: The uterus volume shows a shrinkage after 6 months treatment with the I M-depot in median by 58.3 % (p = 0.0005) and in the 3M-depot group by 55.2% (p = 0.0001). The volume of the largest myomata decreased in median from baseline after 6 months in the 1M- by 69.1% and in the 3M-depot group by 70.2% (p = 0.0020 and p = 0.0166 respectively). The total symptomscore s howed relief or improvement after a 6 months treatment judged according to Biberoglu and Behrmann [3] in both treatment groups (p < 0.00195). The most frequent side-effects were those due to hormone ablation. Conclusion: The 3M-depot of leuprorelinacetate is with regard to efficacy c omparable to the I M-depot formulation as is the side-effect profile. The 3 M-depot formulation of leuprorelinacetate seems to be a real alternative fo r treatment of uterine fibroids.