Leiomyoma of uterus. Leiomyoma of uterus, unspecified
Conditions
Interventions
Intervention 1: Intervention Group 1: Participants in the Leuprolide 7.5 mg group (manufactured by Varian Pharmed, Iran) will receive subcutaneous injections every 28 days for 2 cycles. Intervention 2
Sponsors
Vice chancellor for Research, Tabriz University Of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Women aged 18 to 55 years diagnosed with abnormal uterine bleeding Definitive diagnosis of uterine myomas with FIGO score 2–5 and a size of 5 to 10 cm Heavy menstrual bleeding (more than 80 mL per cycle) for at least three consecutive cycles, in cases where surgical intervention is not the primary treatment option Providing informed consent
Exclusion criteria
Exclusion criteria: Pregnancy or breastfeeding Suspected or confirmed gynecologic malignancies (presence of atypical hyperplasia or cancer on endometrial biopsy) Current use of hormonal treatments for AUB History of thromboembolic disorders Severe hepatic or renal disease or uncontrolled diabetes Known hypersensitivity to GnRH agonists Participation in another clinical study within the past 30 days History of prior use of GnRH agonist medications Severe myoma-related bleeding requiring surgical intervention Fibroid-related symptoms such as pelvic pain, or bladder/ bowel pressure requiring surgical management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of menstrual bleeding. Timepoint: Three-month patient follow-up. Method of measurement: Using a bleeding assessment chart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in myoma size and volume. Timepoint: Three months after the start of the intervention. Method of measurement: Transvaginal ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactVahideh Rahmani
Tabriz University of Medical Sciences
Outcome results
None listed