Comparison of treatment outcomes of dienogest alone versus dienogest with zinc in endometriosis:single blind clinical-trial

Comparison of treatment results of dienogest alone and dienogest combined with zinc in endometriosis patients

A two-group, single-blind, phase 3 clinical trial will be conducted on 72 patients with endometriosis and randomized using a block randomization method.

This study is conducted as a clinical trial at Fatemeh Hospital affiliated with Hamadan University of Medical Sciences. The study subjects in the intervention groups are randomly selected from among women with a confirmed diagnosis of endometriosis (diagnosis by laparoscopy or imaging). Blinding is single-blind and only the outcome assessors and data analysts are unaware.

Inclusion criteria: Age 18 to 45 years. Diagnosis of moderate to severe endometriosis. No use of hormone therapy in the past 3 months. No severe comorbidities (such as liver or kidney disease). Exclusion criteria: Pregnancy or planning to become pregnant during the study. Sensitivity to dienogest or zinc. Unwillingness to continue participating in the study. Inaccessibility of the patient to follow up on treatment results

This randomized clinical trial (RCT) will be conducted to compare the effects of dienogest alone and dienogest combined with zinc in the treatment of endometriosis. The first group will receive dienogest alone (dose 2 mg daily) orally and the second group will receive dienogest 2 mg daily + zinc (dose 50 mg daily) orally, once daily.

Comparison of treatment results of dienogest alone and dienogest combined with zinc in endometriosis patients

And using the block randomization method, they will be assigned to two groups A (dienogest alone) and B (dienogest with zinc) using four-blocks. In order to use block randomization, four-blocks are used, which will have 6 blocks in the following order, and each of the blocks will be numbered and will be used for 4 patients, that is, if block number 1 is selected in the lottery, the first patient will receive treatment A, the second patient will receive treatment B, the third patient will receive treatment A, and the fourth patient will receive treatment B. The fifth patient will be selected again by lottery and randomly from one of the blocks, and the type of treatment will be assigned to the fifth to eighth patients, respectively, based on the block. In the block randomization method, it is possible that a block will be selected more than once in the lottery. In this way, two equal groups of 36 patients are placed in 18 blocks of 4.

Due to the different types of interventions, it is not possible to blind the doctor and the patient. Only the person who ultimately evaluates the patients will be unaware of the type of treatment (single blind).