Reproductive endocrinologyA randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata
Section snippets
Study Design and Treatments
This study was prospective, randomized, multicenter, double-blind, and placebo-controlled. All screening evaluations were to be completed within 30 days before the initiation of dosing. Eligible patients were enrolled into the study and randomly assigned to one of three asoprisnil treatment groups (5, 10, and 25 mg) or placebo. A computer-generated central randomization schedule was used to assign each patient in a 1:1:1:1 ratio to the four treatment groups. Study drug was supplied as oral
Demographic Data
A total of 129 premenopausal patients were randomized into the study and received at least one dose of study drug (31 received placebo, 33 received asoprisnil [5 mg], 29 received asoprisnil [10 mg], and 36 received asoprisnil [25 mg]). Overall, there were no important differences in patient demographics across all treatment groups (Table 1). The study population was predominantly Caucasian (73%) and African American (19%). The mean age was 42.6 years (range, 28–50 y), the mean weight was 73.3
Discussion
The results of this double-blind placebo-controlled study demonstrate the clinical potential of asoprisnil for the management of uterine leiomyoma related complaints. A 3-month course of treatment with asoprisnil-controlled uterine bleeding and reduced total uterine volume, as well as that of the dominant leiomyoma. In addition, this treatment was associated with improvements in patient-reported outcomes, including bulk-related symptoms (bloating and pelvic pressure) and global satisfaction
Acknowledgments
The authors thank Gretchen Bodum, R.Ph., for editing the manuscripts and thank Irving Spitz, M.D., for expert comments.
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Supported by TAP Pharmaceutical Products Inc., Lake Forest, Illinois (clinical trial identifier NCT00160459). Walter Elger, M.D., Ph.D., is a consultant for TAP; all other authors were employees of TAP during the writing of this manuscript.
- 1
Present address for Walter Elger, M.D., Ph.D.: Schorlemerallee, Berlin-Dahlem, Germany
- 2
Present address for Craig A. Winkel, M.D., M.B.A.: Georgetown University, Washington, DC