Raloxifene administration in premenopausal women with uterine leiomyomas: A pilot study

Stefano Palomba, Francesco Orio, Michele Morelli, Tiziana Russo, Massimiliano Pellicano, Errico Zupi, Gaetano Lombardi, Carmine Nappi, Pier Luigi Benedetti Panici, Fulvio Zullo

Research output: Contribution to journalArticle

Abstract

This prospective randomized single-blind placebo-controlled clinical trial was carried out to evaluate the effects of raloxifene administration on uterine and leiomyoma sizes in premenopausal women. Ninety healthy premenopausal women affected by asymptomatic uterine leiomyomas were enrolled and treated with raloxifene at the doses of 60 mg/d (group A), 180 mg/d (group B), or placebo (group C). The duration of the treatment was 6 cycles of 28 d each. At entry and after three and six cycles, uterine and leiomyoma sizes were measured by transvaginal ultrasonography. The difference between uterine and leiomyoma volumes (Δ size) was calculated in all subjects. The characteristics of the menstrual cycles and the side effects of the treatments were recorded using a daily diary. The severity of the uterine bleedings was assessed using a rank scale. Throughout the study, no significant changes were observed in uterine and leiomyoma size or in Δ size among the three groups and within each group of treatment. The length and severity of uterine bleedings was not significantly different between the three groups and within each group. In conclusion, raloxifene has no significant effect on uterine and leiomyoma size or on menstrual cycle in premenopausal women.

Original languageEnglish
Pages (from-to)3603-3608
Number of pages6
JournalJournal of Clinical Endocrinology and Metabolism
Volume87
Issue number8
DOIs
Publication statusPublished - 2002

ASJC Scopus subject areas

  • Biochemistry
  • Endocrinology, Diabetes and Metabolism

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    Palomba, S., Orio, F., Morelli, M., Russo, T., Pellicano, M., Zupi, E., Lombardi, G., Nappi, C., Panici, P. L. B., & Zullo, F. (2002). Raloxifene administration in premenopausal women with uterine leiomyomas: A pilot study. Journal of Clinical Endocrinology and Metabolism, 87(8), 3603-3608. https://doi.org/10.1210/jc.87.8.3603