Goserelin acetate [amount hidden] 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

What Was Tested

Researchers studied Goserelin in the context of anemia in this randomized controlled trial publication.

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.

Why It Was Studied

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.

Who Took Part

PubMed indexes the participants as adults, women only.

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.

The tolerability assessment included bone mineral density measurements and subjective symptomatology (ie, menstrual bleeding [uterine hemorrhage], fatigue, pelvic pain, and pelvic pressure).

How the Study Was Run

The researchers set it up as a randomized, double-blind and multicenter study.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

Blinding on both sides kept the participants and researchers unaware of who received Goserelin.

Running at several centres spread the Goserelin study over different clinics and patient groups.

Surgery (hysterectomy or myomectomy) was planned for week 12.

What Was Measured

Topics PubMed links to this paper include Anemia, Iron-Deficiency, Antineoplastic Agents, Hormonal, Ferrous Compounds, Goserelin, Gynecologic Surgical Procedures, Hematinics and Hemoglobins.

What This Means in Plain Language

The paper is a randomized, double-blind and multicenter study of Goserelin in people with anemia.

Results are reported in around 8 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (Clinical therapeutics), a journal based in United States.

More context: the Goserelin compound page, Anemia research.