Clinical trial NCT06543550: Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
Official title: Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Endometriosis
Keywords: Endometriosis
Implantable Gestrinone
Dienogest
Lead sponsor: Bio Meds Pharmaceutica Ltda
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 1:1 ratio. Control Group (n=35) - treatment with oral Dienogest - and Test Group (n=35) - 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 Fisher\&amp;#39;s 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 p\&lt;0.05.

Eligibility criteria: Inclusion Criteria:

* Adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis, who are not undergoing other therapies to treat them.
* Patients must have a diagnosis of Grade 1 or 2 endometriosis assessed by imaging tests (ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation)14, have a BMI of up to 25kg/m2, and weigh between 50 and 70kg.

Exclusion Criteria:

* Pregnant patients (supporting test must be presented)
* Breastfeeding women, using other hormonal contraceptive methods or copper or silver IUDs, who have polycystic ovaries, and/or hyperandrogenism.
* Patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study.
* Patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure
* Patient who are scheduled for surgical treatment during the study period.

Primary outcomes:
measure: Evaluation of dysmenorrhea severity
timeFrame: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
measure: Evaluation of dyspareunia severity
timeFrame: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
measure: Evaluation of non-cyclical pelvic pain severity
timeFrame: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
measure: Evaluation of endometriosis foci regression
timeFrame: Pre-treatment, 6 and 12 months
Secondary outcomes:
measure: Evaluation of quality of life
timeFrame: Pre-treatment, 6 and 12 months
measure: Evaluation of adverse effect
timeFrame: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
measure: Evaluation of abnormal Uterine Bleeding (AUB)
timeFrame: Pre-treatment, 1, 3 , 6 and 12 months
measure: Evaluation of sexual function
timeFrame: Pre-treatment, 1 week, 1, 3 , 6 and 12 months
measure: Evaluation of body composition
timeFrame: Pre-treatment, 3 , 6 and 12 months
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Gm Ignacio Atividade Medica LTDA
state: Distrito Federal
city: Campina Grande
country: Brazil
facility: Instituto Longevite Servicos Medicos LTDA
state: Paraíba
city: São José dos Campos
country: Brazil
facility: Jpml Clinica Medica LTDA
state: São Paulo
city: São Paulo
country: Brazil
facility: Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA
Study officials:
References: