PMID- 17919549
OWN - NLM
STAT- MEDLINE
DCOM- 20071206
LR  - 20141120
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 29
IP  - 8
DP  - 2007 Aug
TI  - Goserelin acetate 10.8 mg plus iron versus iron monotherapy prior to surgery in 
      premenopausal women with iron-deficiency anemia due to uterine leiomyomas: 
      results from a Phase III, randomized, multicenter, double-blind, controlled 
      trial.
PG  - 1682-91
AB  - BACKGROUND: Women with symptomatic uterine leiomyomas (fibroids) may have 
      iron-deficiency anemia (IDA); therefore, surgery places them at risk of 
      blood-borne morbidity from perioperative transfusions. Such women might benefit 
      from a preoperative treatment that restores hematologic normality and alleviates 
      fibroid symptoms. OBJECTIVE: The purpose of this study was to examine the effects 
      of a single preoperative depot injection of goserelin acetate plus iron treatment 
      compared with iron monotherapy, in premenopausal women with IDA due to uterine 
      leiomyomas. METHODS: This Phase III, randomized, multicenter, double-blind, 
      controlled trial (12 weeks of treatment plus a 24-week follow-up period) was 
      conducted from October 1997 to August 1999. Patients received an injection of 
      goserelin acetate 10.8 mg (3-month formulation) or a sham, with both groups 
      receiving PO iron (ferrous sulfate) 325-mg tablets TID during the 12-week 
      treatment period. Surgery (hysterectomy or myomectomy) was planned for week 12. 
      Hemoglobin (Hb) level, symptoms of uterine leiomyomas, requirement for blood 
      transfusion throughout, ability to donate blood for autologous transfusion, and 
      leiomyoma and uterine volume were assessed for efficacy. The tolerability 
      assessment included bone mineral density measurements and subjective 
      symptomatology (ie, menstrual bleeding [uterine hemorrhage], fatigue, pelvic 
      pain, and pelvic pressure). RESULTS: A total of 110 women received treatment (n = 
      54, goserelin acetate 10.8 mg; n = 56, sham). The majority of patients (69.1%) 
      were black and the mean age at study entry was 39.9 years, with a mean weight of 
      80.1 kg. At approximately 12 weeks, Hb levels were significantly higher in the 
      goserelin group compared with the sham group (difference of least squares mean, 
      1.17 g/dL; 95% CI, 0.68-1.66; P < 0.001), and significantly more patients in the 
      goserelin group had an increase in Hb concentration of >or=2 g/dL (odds ratio 
      6.36; 95% CI, 2.00-20.18; P < 0.001). A nonsignificant decrease in both uterine 
      and leiomyoma volume was experienced by patients who administered goserelin 
      compared with increases in the sham group. Uterine hemorrhage was also 
      experienced numerically less often by goserelin-treated patients compared with 
      those given the sham injection (9.3% vs 28.6%, respectively). One or more adverse 
      events (AEs) were reported by 89% of patients in each treatment group. Goserelin 
      acetate 10.8 mg was generally well tolerated by patients, with no serious 
      drug-related AEs reported during this 36-week trial. CONCLUSION: A single, 
      preoperative injection of goserelin acetate 10.8 mg in addition to PO iron 325 mg 
      TID was associated with improved Hb levels in these premenopausal women with IDA 
      due to uterine leiomyomas.
CI  - Copyright 2007 Excerpta Medica, Inc.
FAU - Muneyyirci-Delale, Ozgul
AU  - Muneyyirci-Delale O
AD  - State University of New York Health Center at Brooklyn, Brooklyn, New York 
      11203-2098, USA. Ozgul.Muneyyirci-Delale@downstate.edu
FAU - Richard-Davis, Gloria
AU  - Richard-Davis G
FAU - Morris, Tom
AU  - Morris T
FAU - Armstrong, Jon
AU  - Armstrong J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (Ferrous Compounds)
RN  - 0 (Hematinics)
RN  - 0 (Hemoglobins)
RN  - 0F65R8P09N (Goserelin)
RN  - 39R4TAN1VT (ferrous sulfate)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Anemia, Iron-Deficiency/blood/*drug therapy/etiology
MH  - Antineoplastic Agents, Hormonal/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Ferrous Compounds/administration & dosage/adverse effects/*therapeutic use
MH  - Goserelin/administration & dosage/adverse effects/*therapeutic use
MH  - *Gynecologic Surgical Procedures
MH  - Hematinics/administration & dosage/adverse effects/*therapeutic use
MH  - Hemoglobins/metabolism
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Leiomyoma/blood/complications/*drug therapy/surgery
MH  - North America
MH  - *Premedication
MH  - Premenopause
MH  - Time Factors
MH  - Treatment Outcome
MH  - Uterine Neoplasms/blood/complications/*drug therapy/surgery
EDAT- 2007/10/09 09:00
MHDA- 2007/12/07 09:00
CRDT- 2007/10/09 09:00
PHST- 2007/03/28 00:00 [accepted]
PHST- 2007/10/09 09:00 [pubmed]
PHST- 2007/12/07 09:00 [medline]
PHST- 2007/10/09 09:00 [entrez]
AID - S0149-2918(07)00259-7 [pii]
AID - 10.1016/j.clinthera.2007.08.024 [doi]
PST - ppublish
SO  - Clin Ther. 2007 Aug;29(8):1682-91. doi: 10.1016/j.clinthera.2007.08.024.