Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
NCT Number: NCT06543550
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Endometriosis
Interventions: DRUG: Implantable gestrinone|DRUG: Oral Dienogest
Sponsor: Bio Meds Pharmaceutica Ltda
Sex: FEMALE
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-30
Completion Date: 2025-10
Locations: Gm Ignacio Atividade Medica LTDA, Brasília, Distrito Federal, 70.390-150, Brazil|Instituto Longevite Servicos Medicos LTDA, Campina Grande, Paraíba, 58.400-506, Brazil|Jpml Clinica Medica LTDA, São José dos Campos, São Paulo, 12.246-876, Brazil|Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA, São Paulo, 05.688-021, Brazil

Summary:
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.

Primary Outcome Measures: Evaluation of dysmenorrhea severity, Patients will be instructed to rate the intensity of dysmenorrhea at each visit after the first month of treatment, using a modified verbal scale from 0 to 3, as suggested by Biberoglu and Behrman. Patients should also rate the intensity of the symptoms using a 100 mm visual analogue scale., Pre-treatment, 1 week, 1, 3 , 6 and 12 months|Evaluation of dyspareunia severity, Patients will be instructed to rate the intensity of deep dyspareunia at each visit after the first month of treatment, using a modified verbal scale from 0 to 3, as suggested by Biberoglu and Behrman. Patients should also rate the intensity of the symptoms using a 100 mm visual analogue scale., Pre-treatment, 1 week, 1, 3 , 6 and 12 months|Evaluation of non-cyclical pelvic pain severity, Patients will be instructed to rate the intensity of pelvic pain (outside the menstrual period), at each visit after the first month of treatment, using a modified verbal scale from 0 to 3, as suggested by Biberoglu and Behrman. Patients should also rate the intensity of the symptoms using a 100 mm visual analogue scale., Pre-treatment, 1 week, 1, 3 , 6 and 12 months|Evaluation of endometriosis foci regression, Assessment of endometriosis lesions and endometrial thickness on Transvaginal Ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation - All patients will be referred, at pre-treatment and at 6 and 12 month visits, to undergo transvaginal ultrasound to assess the presence or absence of endometriotic lesions, in addition to controlling the thickness of the endometrium., Pre-treatment, 6 and 12 months
Secondary Outcome Measures: Evaluation of quality of life, The evaluation of the influence of complaints on the impact of endometriosis on patients' quality of life will be carried out using the EHP-30 questionnaires validated for the Portuguese language., Pre-treatment, 6 and 12 months|Evaluation of adverse effect, Evaluation of sings and symptoms. In addition, it will be evaluated at each visit the serum levels of Estradiol, Sex Hormone Binding Globulin (SHBG), Progesterone, Total and free Testosterone, FSH, LH, Hepatic transaminase (TGO, TGP, GGT), Total cholesterol and fractions, Triglycerides, Red cell concentration, Coagulation factors , Homocysteine, Fibrinogen, DHT., Pre-treatment, 1 week, 1, 3 , 6 and 12 months|Evaluation of abnormal Uterine Bleeding (AUB), The duration and intensity of menstrual flow will be recorded pre-treatment and at each visit after the first month of treatment. Abnormal uterine bleeding will be defined as a PBAC (Pictorial blood loss assessment chart) score greater than 100., Pre-treatment, 1, 3 , 6 and 12 months|Evaluation of sexual function, The assessment of sexual function (desire, excitement, lubrication, orgasm, satisfaction and pain) will be carried out through the application of the Female Sexual Function Index., Pre-treatment, 1 week, 1, 3 , 6 and 12 months|Evaluation of body composition, Body composition will be assessed using the tetrapolar Bioimpedance test with the Indoby device (weight, percentage of lean mass and fat mass), Pre-treatment, 3 , 6 and 12 months