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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20141230020486N6

Enrollment

Registered

2024-11-13

Start date

2025-01-04

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Endometriosis disease. Condition 2: Endometriosis of rectovaginal septum. Endometriosis of pelvic peritoneum Endometriosis of rectovaginal septum and vagina

Interventions

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 uterin

Eligibility

Sex/Gender

Female

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeili Hafizi Lotfabadi

Mashhad University of Medical Sciences

hafizil@mums.ac.ir+98 51 3843 0634

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026