Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543550
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis
Detailed Description:
Patient recruitment will be carried out on a prospective basis and based on the group of patients from the private Medical Clinics in 4 cities Campina Grande - Pb São Paulo - SP São José dos Campos - SP and Brasilia-DF The study will include 70 adult female patients of menstrual age pre-menopause 18 to 45 years old who seek medical treatment to alleviate complaints related to endometriosis The selected patients will be randomly allocated into two groups in a 11 ratio Control Group n35 - treatment with oral Dienogest - and Test Group n35 - Implantation of Gestrinone pellets Follow-up visits will be scheduled after 1 week and 1 3 6 9 and 12 months of initiation of therapy Therapies will be compared with respect to the effects on the severity of dysmenorrhea dyspareunia and non-cyclical pelvic pain Verbal Scale and Visual Analogue Scale level of Uterine Bleeding assessed by PBAC systemic effects hormonal hepatic lipid profile cell concentration red clotting factor - assessed through blood tests endometriosis lesions endometrial thickness transvaginal ultrasound body composition bioimpendance test quality of life EHP30 and sexual function female sexual function index - FSFI Data analysis will be carried out using validated statistical software Chi-square or Fisheramp39s exact tests will be used to compare qualitative variables while independent t-tests will be used to compare quantitative variables between the two groups Analysis of variance with repeated measures will be used to compare the average pain intensity over time The significance level for all tests will be plt005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None