Document Detail

Long-term safety and tolerability of flutamide for the treatment of hirsutism.
MedLine Citation:
PMID:  18339379     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To evaluate the long-term safety and tolerability of flutamide therapy for hirsutism. DESIGN: Prospective observational study. SETTING: Gynecology department in a teaching hospital. PATIENT(S): Hyperandrogenic women presenting for hirsutism treatment were followed between January 2000 and January 2007. INTERVENTION(S): Women received flutamide 250 mg/day alone (n = 27) or combined with a fixed dose of an oral contraceptive containing 0.020 mg of ethinyl estradiol (EE) and 0.15 mg of desogestrel (n = 56). MAIN OUTCOME MEASURE(S): Adverse events, safety, tolerability and efficacy were assessed every 6 months during the follow-up. Liver and lipid profiles were also recorded. RESULT(S): Patients under flutamide therapy showed, compared with basal values, a significant progressive decrease in hirsutism scores after 6 months of treatment with a maximum effect at 12 months that was maintained during the 84 months of follow-up. A total of 40.96% women presented one or more adverse effects during the follow-up; 33.73% showed at least one adverse effect possibly related with the study drug, and 24.09% withdrew from the study because of adverse effects. During the follow-up, as many as 59% of patients abandoned the study. CONCLUSION(S): Flutamide is very effective for hirsutism treatment; however, adverse effects are very frequent and associated with low long-term compliance.
Camil Castelo-Branco; Dolores Moyano; Olga Gómez; Juan Balasch
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Publication Detail:
Type:  Clinical Trial; Journal Article     Date:  2008-03-12
Journal Detail:
Title:  Fertility and sterility     Volume:  91     ISSN:  1556-5653     ISO Abbreviation:  Fertil. Steril.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-03-30     Completed Date:  2009-05-01     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372772     Medline TA:  Fertil Steril     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1183-8     Citation Subset:  IM    
Faculty of Medicine-University of Barcelona, Institut Clinic of Gynecology, Obstetrics and Neonatology, Hospital Clinic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
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MeSH Terms
Androgen Antagonists / adverse effects,  therapeutic use
Contraceptives, Oral, Hormonal / administration & dosage,  adverse effects
Desogestrel / administration & dosage,  adverse effects
Ethinyl Estradiol / administration & dosage,  adverse effects
Flutamide / administration & dosage,  adverse effects*,  therapeutic use*
Follow-Up Studies
Hirsutism / drug therapy*
Time Factors
Treatment Outcome
Young Adult
Reg. No./Substance:
0/Androgen Antagonists; 0/Contraceptives, Oral, Hormonal; 13311-84-7/Flutamide; 54024-22-5/Desogestrel; 57-63-6/Ethinyl Estradiol

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