Overview
Clinical Trial the Use of Levonorgestrel-releasing Intrauterine System Versus Etonogestrel Implant in Endometriosis
Status:
Completed
Completed
Trial end date:
2017-08-01
2017-08-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
Randomized clinical trial the use of levonorgestrel releasing intrauterine system. Objectives: To evaluate and compare the efficacy of- levonorgestrel releasing intrauterine system l(LNG-IUS) in relation to the subdermal implant releasing etonogestrel (ENG) in the control of chronic pelvic pain and / or dysmenorrhea in women endometriosis.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of Campinas, BrazilTreatments:
Desogestrel
Etonogestrel
Levonorgestrel
Criteria
Inclusion Criteria:- Women aged 18 to 45
- Absence of pregnancy
- Patients with chronic pelvic pain and / or dysmenorrhea with pain scores ≥ 4 on EVA
pain and surgical and histopathological diagnosis of endometriosis in 14 last three
months to two years, according to the current classification of the American Society
for Reproductive Medicine and Enzian classification.
- Accept participate and sign the consent form and clarified
Exclusion criteria:
- Current wish to get pregnant
- I just want to use the LNG-IUS as treatment
- Contraindication to the use of LNG-IUS: Current pelvic inflammatory disease or
appellant; infection of the lower genital tract; infected abortion during the last 3
months; purulent cervicitis; uterine or cervical malignancy; bleeding abnormal uterine
undiagnosed; congenital uterine anomalies or acquired conditions associated with
increased susceptibility to infections; acute liver disease or liver tumors;
hypersensitivity to LNG.
- Contraindications to the use of ENG implants: pregnancy or suspected pregnancy;
- Active venous thromboembolic disorder; presence or history of liver disease serious as
liver function values have not returned to normal; progestogen dependent tumors;
abnormal bleeding undiagnosed; hypersensitivity to any component of implante.
- Abusive use of alcohol and / or other illicit drugs.