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A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata Kristof Chwalisz, M.D., Ph.D., Lois Larsen, Ph.D., Cynthia Mattia-Goldberg, M.S., Anthony Edmonds, M.S., Walter Elger, M.D., Ph.D., Craig A. Winkel, M.D., M.B.A. Fertility and Sterility Volume 87, Issue 6, Pages (June 2007) DOI: /j.fertnstert Copyright © 2007 American Society for Reproductive Medicine Terms and Conditions
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FIGURE 1 Schematic of study design. A prospective, multicenter, randomized, placebo-controlled, double-blind, parallel-group study of asoprisnil (5, 10, or 25 mg) administered orally once daily for 12 weeks; treatment visits were conducted at weeks 2, 4, 8, and 12. Chwalisz. Treatment of leiomyomata with asoprisnil. Fertil Steril 2007. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2007 American Society for Reproductive Medicine Terms and Conditions
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FIGURE 2 Suppression of uterine bleeding during treatment with asoprisnil. Suppression of uterine bleeding was defined as having no light, medium, and heavy bleeding from the end of baseline menses through the end of dosing. **P≤.01 and ***P≤.001 compared with placebo, by using Fisher’s exact test. Chwalisz. Treatment of leiomyomata with asoprisnil. Fertil Steril 2007. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2007 American Society for Reproductive Medicine Terms and Conditions
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FIGURE 3 Effects of asoprisnil on the volume of the largest leiomyoma and uterine volume during 12 weeks of treatment. (A) Leiomyoma volume was assessed at baseline as well as during treatment at weeks 4, 8, and 12 using transvaginal or abdominal ultrasound. The results are presented as median percentage changes from baseline. *P≤.05 compared with placebo by using a Kruskal-Wallis test and Hochberg’s multiple-comparison procedure. (B) The uterine volume was assessed at baseline and during treatment at weeks 4, 8, and 12, by using transvaginal or abdominal ultrasound. The results are presented as median percentage changes from baseline. *P≤.05 compared with placebo by using a Kruskal-Wallis test and Hochberg’s multiple comparison procedure. Chwalisz. Treatment of leiomyomata with asoprisnil. Fertil Steril 2007. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2007 American Society for Reproductive Medicine Terms and Conditions
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FIGURE 4 Effects of asoprisnil on bloating and pelvic pressure during 12 weeks of treatment. Mean scores for bloating (A) and pelvic pressure (B) at baseline and at weeks 4, 8, and 12 in the patients receiving asoprisnil and placebo. *Statistically significant difference from placebo at the .05 level, using a Cochran-Mantel-Haenszel (CMH) test with baseline scores as strata. **Statistically significant difference from placebo at the .01 level, using a CMH test with baseline scores as strata. ***Statistically significant difference from placebo at the .001 level, using a CMH test with baseline scores as strata. Chwalisz. Treatment of leiomyomata with asoprisnil. Fertil Steril 2007. Fertility and Sterility , DOI: ( /j.fertnstert ) Copyright © 2007 American Society for Reproductive Medicine Terms and Conditions
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