Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis

Bio Meds Pharmaceutica Ltda

Status and phase: Enrolling; Phase 4

Conditions: Endometriosis

Treatments: Drug: Implantable gestrinone; Drug: Oral Dienogest

Study type: Interventional

Funder types: Industry

Identifiers

NCT06543550

CS.001

Details and patient eligibility

About

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

Full 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'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<0.05.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Implantable Gestrinone

Experimental group

Description:

Implantation of Gestrinone pellets - Eligible patients will undergo implantation of Gestrinone pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region, using aseptic technique under local anesthesia. Patients will use 1.6mg/kg of weight to treat endometriosis. A second implantation procedure will be performed 6 months after the first, allowing evaluation of the effects of the therapy over a period of 12 months.

Treatment:

Drug: Implantable gestrinone

Oral Dienogest

Active Comparator group

Description:

Patients will receive the medication to be administered orally at 2mg daily for 12 months.

Treatment:

Drug: Oral Dienogest