GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Leuprolide Acetate Study Group.

Abstract

OBJECTIVE:

To determine the effectiveness of leuprolide acetate depot plus iron compared with iron alone in the preoperative treatment of anemia due to prolonged or excessive bleeding associated with uterine leiomyomas.

METHODS:

This was a phase III, stratified, randomized, double-blind, placebo-controlled, parallel-group, 12-week multicenter study. Enrolled patients had hemoglobin levels of 10.2 g/dL or less and/or hematocrit values of 30% or less. Patients were entered into one of two strata based on their pre-study hematocrit level: stratum A, hematocrit less than or equal to 28%, and stratum B, hematocrit greater than 28%. Patients within each stratum were randomized to one of three treatment arms: leuprolide acetate depot 7.5 mg, leuprolide acetate depot 3.75 mg, or placebo. All patients received iron orally. Response was defined as a hemoglobin level of 12 g/dL or more and a hematocrit value of 36% or greater.

RESULTS:

Three hundred nine patients were entered into the study, of whom 265 were evaluated. Using our response criteria, a significantly greater number of patients in both leuprolide acetate groups (combined strata) responded to therapy than did those in the placebo group: 74% in each leuprolide acetate group versus 46% in the placebo group (P < .001). Gonadotropin-releasing hormone agonist-treated patients had a significant reduction in uterine and myoma volume when compared with the placebo group (P < .01). Hot flashes and vaginitis were reported significantly more often (P < .001) in the leuprolide acetate-treated groups than in the placebo group.

CONCLUSION:

Both dosages of GnRH agonist plus iron were more effective than iron alone in treating the anemia of patients with uterine leiomyomas, in reducing uterine-myoma volume, and in alleviating bleeding and other leiomyoma-related symptoms.

• Authors: T G Stovall, O Muneyyirci-Delale, R L Summitt Jr, A R Scialli
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 86 Issue 1 Pg. 65-71 (Jul 1995) ISSN: 0029-7844 [Print] United States
• PMID: 7784025 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Delayed-Action Preparations
• Hemoglobins
• Iron
• Leuprolide

Topics

• Adult
• Anemia, Iron-Deficiency (blood, drug therapy, etiology)
• Bone Density
• Delayed-Action Preparations
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Hematocrit
• Hemoglobins (analysis)
• Humans
• Iron (therapeutic use)
• Leiomyoma (complications, pathology, surgery)
• Leuprolide (therapeutic use)
• Middle Aged
• Preoperative Care
• Uterine Hemorrhage (complications, etiology)
• Uterine Neoplasms (complications, pathology, surgery)