Evaluation of serum levels of tumor biomarkers CA-125, CD23 and nerve fiber density in patients with pelvic pain and endometriosis. Health conditions studied: endometriosis
Conditions
Interventions
This research protocol refers to the extension of another 180-day clinical trial in which 103 participants with pain and endometriosis were randomized, of which 51 participants received the levonorges
assessment of the depth and pain dyspareunia score by analogical pain scale with 12, 18 and 24 months of use of the intervention
Mode of medication administration: as it is an extension of another research protocol, the participants already have the levonorgestrel-releasing intrauterine system or the Etonogestrel Subdermal Impl
Drug
Sponsors
faculdade de ciencias medicas da universidade estadual de campinas
faculdade de ciencias medicas da universidade estadual de campinas
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women between age 18 to 45 years old, who entered at the study at the time of randomization and did not discontinue follow-up until the last visit in the previous study, 180 days after device insertion, these women already have a diagnosis and surgical staging or endometriosis imaging method (according to ASRM, 1997) and have reported chronic pelvic pain and / or dysmenorrhea with pain scores greater than or equal to 4 on the visual analog pain scale in the moment of randomization; agree to participate in the study and sign the informed consent term
Exclusion criteria
Exclusion criteria: Pregnancy; current proposoal to get pregnant; desire to only use the LNG-IUS as treatment and control of pain due to endometriosis; personal history of uterine Mullerian malformation or acquired uterine abnormalities, such as synechiae, or surgical absence of uterus; contraindications to the use of the LNG-SIU: current or recurrent pelvic inflammatory disease; acute infection of lower genital tract; present purulent cervicitis; history of miscarriage in the last three months; history of puerperal infection in the last three months; malignant uterine, cervical, hormone-dependent tumors; genital uterine bleeding with uncertain or undiagnosed etiology; conditions associated with increased susceptibility to infections; acute liver disease or malignant liver tumors; acute thromboembolism; hypersensitivity to levonorgestrel; contraindications to the use of the ENG implant: acute thromboembolism; malignant uterine tumors, hormones-dependent; genital uterine bleeding with uncertain or undiagnosed etiology; acute liver disease or malignant liver tumors; hypersensitivity to etonorgestrel or to any component of the implant; abuse of illicit drugs or alcohol; morbid obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: After twenty-four months of observation, levels of CA-125 and CD-23 will be reduced to within normal levels (<35 U / ml and <5 U / ml, respectively) with the use of the SIU- LNG;Expected outcome 2: after twenty-four months of observation, levels of CA-125 and CD-23 will be reduced to within normal levels (<35 U / ml and <5U / ml, respectively) with the use of the subdermal implant from ENG;Expected outcome 3: after twenty-four months of observation there will be reduction of pain score and depth dyspareunia for absence of pain or mild pain with the use of the LNG-IUS and with the use of the subdermal implant of ENG | — |
Secondary
| Measure | Time frame |
|---|---|
| There will be significant differences in serum levels of CA-125 and CD-23 markers between ENG and LNG-IUS users. There will be a greater chance of reduction to normal levels in the serum concentrations of these CA-125 biomarkers (<35U / ml and CD-23 <5U / ml) in ENG implant users, due to the fact that it blocks ovulation in more than 95% of the users. | — |
Countries
Brazil
Contacts
Public Contactdeborah r goncalves
unicamp
Outcome results
None listed