]>
IRCT20141230020486N6 IRCT 2024-11-13 Mashhad University of Medical Sciences The effect of Mirena IUD in reducing pain of endometriosis Assessing the effects of levonorgestrel-releasing intrauterine system in reducing pain in women with endometriosis 2025-01-04 anticipated 43 Complete https://irct.ir/trial/79510 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2-3 Condition 1: Endometriosis disease. Condition 2: Endometriosis of rectovaginal septum. Intervention group: Placement of 52 mg levonorgestrel-releasing intrauterine system (Mirena IUD) (releasing 20 micrograms of levonorgestrel in 24 hours), made by Bayer Company, Germany, in the uterine cavity of patients with endometriosis on an outpatient setting in the clinic. The IUD can remain in the uterus for up to 5 years.. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after making individuals unidentifiable When: Starting 6 months after publication To whom: People working in academic institutions Conditions: Mention the source Where to obtain: Dr. Leili Hafizi / Email: hafizil@mums.ac.ir / Phone: 09153107633 How to obtain: Reply to email within a maximum of one week Comments:
public Leili Hafizi Lotfabadi
Olum Blvd., Daneshgah Town
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3843 0634 hafizil@mums.ac.ir Mashhad University of Medical Sciences scientific Leili Hafizi Lotfabadi
Olum Blvd., Daneshgah Town
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3843 0634 hafizil@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with definitive diagnosis of endometriosis through imaging having pain caused by endometriosis Regular menstrual periods (between 25 and 35 days) Not using hormonal therapy for more than 6 months before the study Desire to have contraception Not using NSAID analgesics Body mass index between 18.5 and 27.5 kg/m2 body 20 years 45 years Female Undiagnosed vaginal bleeding Chronic diseases (eg liver problems, diabetes or pelvic inflammatory disease) History of septic abortion in the last three months Use of hormonal contraception and IUD during the last 3 months Pregnancy or breastfeeding in the last 3 months Suspected malignancy in biopsy Desire to pregnancy Uterine size greater than 10 weeks of gestation Submucosal leiomyoma or polyp History of osteoporosis Coagulopaties or allergy to progestins N80.3 N80.4 Endometriosis of pelvic peritoneum Endometriosis of rectovaginal septum and vagina Treatment - Devices Intervention group: Placement of 52 mg levonorgestrel-releasing intrauterine system (Mirena IUD) (releasing 20 micrograms of levonorgestrel in 24 hours), made by Bayer Company, Germany, in the uterine cavity of patients with endometriosis on an outpatient setting in the clinic. The IUD can remain in the uterus for up to 5 years. Score of dysmenorrhea, based on the Numeric Pain Rating Scale. Timepoint: Measurement of dysmenorrhea score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD. Method of measurement: Based on the Numeric Pain Rating Scale index. Score of dyspareunia, based on the Numeric Pain Rating Scale. Timepoint: Measurement of dyspareunia score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD. Method of measurement: Based on the Numeric Pain Rating Scale index. Score of dyschezia, based on the Numeric Pain Rating Scale. Timepoint: Measurement of dyschezia score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD. Method of measurement: Based on the Numeric Pain Rating Scale index. Score of non-cyclic pelvic pain, based on the Numeric Pain Rating Scale. Timepoint: Measurement of non-cyclic pelvic pain score at the beginning of the study (before the intervention) and 6 months after placement of the mirena IUD. Method of measurement: Based on the Numeric Pain Rating Scale index. Cancer Antigen 125. Timepoint: Measurement of Cancer Antigen 125 at the beginning of the study (before the intervention) and 6 months after placement of the levonorgestrel-releasing intrauterine system (mirena). Method of measurement: Based on serum CA125 protein level test (U/ml). Mashhad University of Medical Sciences Approved 2024-09-16 Ethics committee of Mashhad University of Medical Sciences Vice Chancellor for Research and Technology, Ghoreshi Bulding, Next to Hoveyzeh Cinema, Daneshgah Ave. Mashhad Razavi Khorasan Iran (Islamic Republic of)