Comparison of the effect of cabergoline, letrozole and triptorelin on the treatment of uterine myomas: a randomized clinical trial

Comparison of the effect of cabergoline, letrozole and triptorelin on the treatment of uterine myomas.

A randomized, parallel group, and single-blind trial without control group, phase 3 on 75 patients. Randomization will be computerized with concealed randomization sequence.

Setting: The gynecology clinic of Akbarabadi hospital, Tehran. Design: a parallel-group, single-blind, and randomized clinical trial on 75 patients with uterine myoma. Patients and data analyzer are unaware while physician is aware about the type of treatments. Interventions: Patients will be randomly divided into three groups and treated for 3 months from the first day of menstrual cycle. Respectively, the first, second, and third groups will be received letrozole (2.5 mg/day orally), cabergoline (0.5 mg/week), and triptorelin (2 mg once month) through intramuscular injection. Every three months, the effect of treatments on uterine myoma size, uterine size (ultrasonography), bleeding amount, the levels of lactate dehydrogenase, serum iron, and hemoglobin will be examined every three months.

Inclusion criteria: 20-45 years old women with uterine myoma. Exclusion criteria: patients above 45 years with a hemoglobin ≥ 9 g/dL, sustained myoma, severe bleeding, kidney and/or liver diseases, and anti-psychotic drug consumers.

Control group: None First intervention group: Patients will be received letrozole (2.5 mg/day, orally) from the first to the 5th day of the menstrual cycle for 3 months. Second intervention group: Patients will be received cabergoline (0.5 mg/week, orally) for 3 months. Third intervention group: Patients will be received tryptorlin (2 mg) through intramuscular injection every 4 weeks for 3 months.

Uterine size; uterine bleeding amount; uterine myoma size

Randomization type: Block randomization:blocks with size of 6 Randomization tool: www.sealedenvelope.com Random sequence concealment: Each patient's drug is placed into a matte envelope and an unique code assigned by www.sealedenvelope.com is pasted on every envelope.

This is a single blinded study. Drug intervention is the same for the three groups in terms of shape, color or appearance of drugs. Patients as well as data analyzer are unaware about the type of groups while physician investigator is aware about the type of groups or treatment intervention.