Document Detail

Long-term administration of tibolone plus gonadotropin-releasing hormone agonist for the treatment of uterine leiomyomas: effectiveness and effects on vasomotor symptoms, bone mass, and lipid profiles.
MedLine Citation:
PMID:  10560995     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the effects of long-term administration of GnRH agonist (GnRH-a) plus tibolone for uterine leiomyomatosis. DESIGN: Prospective open clinical trial. SETTING: Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples "Federico II", Naples, Italy. PATIENT(S): Twenty-five subjects with symptomatic uterine leiomyomas. INTERVENTION(S): Treatment for 2 years with leuprolide acetate (3.75 mg IM every 28 days) and tibolone (2.5 mg/d per os). MAIN OUTCOME MEASURE(S): Uterine and uterine leiomyoma sizes, endometrial thickness, lumbar spine bone mineral density (BMD), bone metabolism, lipid profile, myoma-related symptoms at baseline and every 6 months. Hot flashes and vaginal bleeding episodes recorded in a daily symptom diary. RESULT(S): After 6 months of treatment, a significant reduction was observed in uterine and leiomyoma volumes and myoma-related symptoms compared with baseline values. No significant change was observed in bone turnover, lumbar BMD, or serum total cholesterol, low-density lipoprotein cholesterol, or triglyceride levels. High-density lipoprotein cholesterol values were significantly lower than baseline values after 6 months of treatment but not after 18 months of therapy. A low mean number of hot flashes per day was observed. CONCLUSION(S): Long-term administration of GnRH-a plus tibolone reduces hot flashes and prevents bone loss without changing the lipid profile.
S Palomba; P Affinito; C Di Carlo; G Bifulco; C Nappi
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Fertility and sterility     Volume:  72     ISSN:  0015-0282     ISO Abbreviation:  Fertil. Steril.     Publication Date:  1999 Nov 
Date Detail:
Created Date:  1999-12-07     Completed Date:  1999-12-07     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0372772     Medline TA:  Fertil Steril     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  889-95     Citation Subset:  IM    
Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Naples Federico II, Italy.
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MeSH Terms
Antineoplastic Agents, Hormonal / therapeutic use*
Bone Density / drug effects*
Endometrium / pathology
Gonadotropin-Releasing Hormone / agonists*
Leiomyoma / drug therapy*
Lipid Metabolism
Middle Aged
Norpregnenes / administration & dosage*
Time Factors
Uterine Neoplasms / drug therapy*
Vasomotor System / drug effects*
Reg. No./Substance:
0/Antineoplastic Agents, Hormonal; 0/Norpregnenes; 33515-09-2/Gonadotropin-Releasing Hormone; 5630-53-5/tibolone
Comment In:
Fertil Steril. 2001 Jul;76(1):216-7   [PMID:  11467296 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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