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Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Unknown statusNot applicableNCT02556411
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population. The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone

Study details

Official title
Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P
Conditions
Interventions
  • Drug: LNG-IUS 13,5 mg Levonorgestrel
  • Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
Sponsor
University of Cagliari
Start date
2021-06-01
Primary completion
2021-12-01
Sex
Female
Age range
from 18 Years to 40 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Total sites listed
0

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Women affected by adenomyosis with pelvic pain \> 4; * Negative Pap Smear test Exclusion Criteria: * Pregnancy or research of pregnancy * Refusal or inability to sign informed consent * Severe underlying comorbidities (hepatic, oncological) * Pelvic inflammatory disease * Other cervical or uterine pathologies * Deep venous thromboembolism * Hormonal therapy contraindications * Smoke

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02556411