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Study aim
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Determine the effect of cabergoline on reducing endometrium in patients with endometriosis
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Design
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This study is three-blind, so that a researcher, a subject and a statistical analyst are unaware of the allocation of the two groups to the study. Since the administration of the drug is in combination with other drugs, the subject is not aware of the status of allocation to the groups. A researcher measuring clinical and diagnostic measures will not be aware of the status of the individual, and the statistician will be unaware of the allocation of people to study groups. Only the observer will be aware of the allocation of the groups. For random assignment, a random block method is used such that individuals use random numbers in quadrilateral blocks. In each group, 32 patient were enrolled in the study.
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Settings and conduct
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Patients will be included in the study after having explained the study of written consent and ensuring that the criteria for entering the study are randomized and will be assigned to one of two groups according to the randomized randomization strategy and this process will continue until the sample size is completed. . Three months later, the size of the endometrium and the changes will be reviewed. For both groups, the subjects will be measured with transvaginal ultrasonography before and after the intervention, then the mean sizondometrium will be measured.
This study is carried out at Rasoul-e-Akram Hospital. The study is three-blind, so that the researcher, the subject and the statistical analyst are unaware of the allocation of the two groups to the study. Since the administration of the drug is in combination with other drugs, the subject is not aware of the status of allocation to the groups. A researcher measuring clinical and diagnostic measures will not be aware of the status of the individual, and the statistician will be unaware of the allocation of people to study groups. Only the observer will be aware of the allocation of the groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include one-sided endometrium, less than 5 cm in size, a lack of ultrasound criteria for malignancy, a lack of a malignancy-based measure, an informed consent to enter the study
Exclsoin criteria: Dissatisfaction for inclusion in the study, Hormonal therapy including Contraceptive 3 months, sensitivity to cabergolin, age over 45
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Intervention groups
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In the intervention group, cabergoline is given 0.5 mg twice a week for 12 weeks and control group is receiving placebo
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Main outcome variables
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size of endometrioma