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Effects of raloxifene treatment on uterine leiomyomas in postmenopausal women.

Abstract

OBJECTIVE

To evaluate the effects of raloxifene administration on uterine and uterine leiomyoma sizes in postmenopausal women.

DESIGN

Prospective randomized, double-blind, placebo-controlled clinical trial.

SETTING

Department of Gynecology, Obstetrics, and Pathophysiology of Human Reproduction, University of Naples "Federico II", Italy.

PATIENT(S)

Seventy spontaneous postmenopausal women affected by uterine leiomyomas.

INTERVENTION(S)

Twelve cycles (of 28 days each) of treatment with raloxifene (60 mg daily per os) or placebo.

MAIN OUTCOME MEASURE(S)

At entry and at every 3 cycles, uterine and uterine leiomyoma dimensions were measured by means of transvaginal ultrasound. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of uterine bleeding and the side effects of the treatments were assessed using a daily diary.

RESULT(S)

After 6, 9, and 12 cycles of therapy, in subjects treated with raloxifene, the mean uterine and uterine leiomyoma size were significantly decreased, and the mean Delta size significantly increased in comparison with basal values and the placebo group. No significant differences in uterine bleeding were detected between the two groups.

CONCLUSION(S)

In postmenopausal women raloxifene appears to act selectively on uterine leiomyomas, reducing their size.

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  • Authors+Show Affiliations

    ,

    Department of Obstetrics and Gynecology, University of Naples "Federico II", Naples, Italy. stefanopalomba@tin.it

    , , , ,

    Source

    Fertility and sterility 76:1 2001 Jul pg 38-43

    MeSH

    Double-Blind Method
    Estrogen Antagonists
    Female
    Humans
    Leiomyoma
    Middle Aged
    Postmenopause
    Raloxifene Hydrochloride
    Treatment Outcome
    Ultrasonography
    Uterine Neoplasms
    Uterus

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    11438317

    Citation

    Palomba, S, et al. "Effects of Raloxifene Treatment On Uterine Leiomyomas in Postmenopausal Women." Fertility and Sterility, vol. 76, no. 1, 2001, pp. 38-43.
    Palomba S, Sammartino A, Di Carlo C, et al. Effects of raloxifene treatment on uterine leiomyomas in postmenopausal women. Fertil Steril. 2001;76(1):38-43.
    Palomba, S., Sammartino, A., Di Carlo, C., Affinito, P., Zullo, F., & Nappi, C. (2001). Effects of raloxifene treatment on uterine leiomyomas in postmenopausal women. Fertility and Sterility, 76(1), pp. 38-43.
    Palomba S, et al. Effects of Raloxifene Treatment On Uterine Leiomyomas in Postmenopausal Women. Fertil Steril. 2001;76(1):38-43. PubMed PMID: 11438317.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effects of raloxifene treatment on uterine leiomyomas in postmenopausal women. AU - Palomba,S, AU - Sammartino,A, AU - Di Carlo,C, AU - Affinito,P, AU - Zullo,F, AU - Nappi,C, PY - 2001/7/5/pubmed PY - 2001/8/17/medline PY - 2001/7/5/entrez SP - 38 EP - 43 JF - Fertility and sterility JO - Fertil. Steril. VL - 76 IS - 1 N2 - OBJECTIVE: To evaluate the effects of raloxifene administration on uterine and uterine leiomyoma sizes in postmenopausal women. DESIGN: Prospective randomized, double-blind, placebo-controlled clinical trial. SETTING: Department of Gynecology, Obstetrics, and Pathophysiology of Human Reproduction, University of Naples "Federico II", Italy. PATIENT(S): Seventy spontaneous postmenopausal women affected by uterine leiomyomas. INTERVENTION(S): Twelve cycles (of 28 days each) of treatment with raloxifene (60 mg daily per os) or placebo. MAIN OUTCOME MEASURE(S): At entry and at every 3 cycles, uterine and uterine leiomyoma dimensions were measured by means of transvaginal ultrasound. The difference between uterine and leiomyoma volumes (Delta size) was calculated in all subjects. The characteristics of uterine bleeding and the side effects of the treatments were assessed using a daily diary. RESULT(S): After 6, 9, and 12 cycles of therapy, in subjects treated with raloxifene, the mean uterine and uterine leiomyoma size were significantly decreased, and the mean Delta size significantly increased in comparison with basal values and the placebo group. No significant differences in uterine bleeding were detected between the two groups. CONCLUSION(S): In postmenopausal women raloxifene appears to act selectively on uterine leiomyomas, reducing their size. SN - 0015-0282 UR - https://www.unboundmedicine.com/medline/citation/11438317/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015-0282(01)01849-0 DB - PRIME DP - Unbound Medicine ER -