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Long-term safety and tolerability of flutamide for the treatment of hirsutism.

AbstractOBJECTIVE:
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.
AuthorsCamil Castelo-Branco, Dolores Moyano, Olga Gómez, Juan Balasch
JournalFertility and sterility (Fertil Steril) Vol. 91 Issue 4 Pg. 1183-8 (Apr 2009) ISSN: 1556-5653 [Electronic] United States
PMID18339379 (Publication Type: Clinical Trial, Journal Article)
Chemical References
  • Androgen Antagonists
  • Contraceptives, Oral, Hormonal
  • Ethinyl Estradiol
  • Flutamide
  • Desogestrel
Topics
  • Adult
  • Androgen Antagonists (adverse effects, therapeutic use)
  • Contraceptives, Oral, Hormonal (administration & dosage, adverse effects)
  • Desogestrel (administration & dosage, adverse effects)
  • Ethinyl Estradiol (administration & dosage, adverse effects)
  • Female
  • Flutamide (administration & dosage, adverse effects, therapeutic use)
  • Follow-Up Studies
  • Hirsutism (drug therapy)
  • Humans
  • Time Factors
  • Treatment Outcome
  • Young Adult

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