NCT01581944

Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Mt. Hope Maternity Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss. In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods. In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.

Detailed description

Variables noted preoperatively: * Age * Parity * Ethnicity * Ultrasound findings Variables noted intra-operatively: * Size of largest fibroid * Estimated blood loss

Conditions

• Fibroids

Interventions

Type	Name	Description
DRUG	2 Doses Goserelin	3.6mg administered monthly for 2 months prior to myomectomy
DRUG	3 Doses Goserelin	3.6mg administered monthly for 3 months prior to myomectomy

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2012-04-20
• Last updated: 2012-04-20

Locations

1 site across 1 country: Trinidad and Tobago