Effect of Aromatase inhibitors combination with oral contraceptive pills versus GnRH agonist on uterine myoma

Phase 3

Recruiting

• Conditions: terine Myoma.; Leiomyoma of uterus

• Registration Number: IRCT20140820018866N7
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Presence of at least one uterine myoma with a size of 2 centimeters (cm) or larger in ultrasound
aged between 20 and 45 years old

Exclusion Criteria

Receiving other therapeutic strategies for treatment of the myoma
Ovarian cyst or neoplasm
Size of largest myoma larger than 10 cm
More than 5 myomas
Endometrial or cervical pathology
exposure to hormonal agents in last month before the trial began
Hepatic, cardiovascular and Renal diseases, peptic ulcer, malignancy, and other serious medical conditions
Pregnancy or lactation
Indication or tendency for surgical intervention

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average vaginal bleeding. Timepoint: Once before the intervention began, then 1, 2 , and 3 months after the intervention began. Method of measurement: pictorial blood assessment chart.;Hemoglobin. Timepoint: Once before and once three months after the intervention began. Method of measurement: Blood Test.;Pelvic Pain. Timepoint: Once before and once three months after the intervention began. Method of measurement: Visual Analog Scale (VAS).;Myoma Size. Timepoint: Once before and once three months after the intervention began. Method of measurement: Ultrasound.;Uterine Size. Timepoint: Once before and once three months after the intervention began. Method of measurement: Ultrasound.;Number of Fibroids. Timepoint: Once before and once three months after the intervention began. Method of measurement: Ultrasound.;Dysmenorrhea. Timepoint: Once before the intervention began, then 1, 2 , and 3 months after the intervention began. Method of measurement: Visual Analog Scale (VAS).