Clinical study to evaluate the blood levels of CA-125 and CD-23 substances and the amount of nerve fibers in the endometrium in patients with pain associated with Endometriosis: before and after 6 months of use of the Levonorgestrel-Releasing Intrauterine System (progesterone hormone IUD) or the Etonogestrel Subdermal Implant (Progesterone Hormone Implant)
- Conditions
- tumor biomarkersA08.675.542nerve fibersEvaluation of serum levels of tumor biomarkers CA-125, CD23 and nerve fiber density in patients with pelvic pain and endometriosis.Health conditions studied: endometriosisC23.888.592.612.944pelvic painD23.101.140
- Registration Number
- RBR-9r8drp
- Lead Sponsor
- faculdade de ciencias medicas da universidade estadual de campinas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.<br>