A Phase 4 interventional study of Implantable gestrinone and Oral Dienogest in Endometriosis, sponsored by Bio Meds Pharmaceutica Ltda. Recruiting at 4 sites in Brazil. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Bio Meds Pharmaceutica Ltda · Phase 4, Interventional, and Treatment
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
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.
901 studies on the registry are indexed under Endometriosis; 259 are open to participants now.
This study's planned enrollment of 70 is close to the median of 64 across 525 interventional studies indexed under Endometriosis.
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Exclusion Criteria:
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.
Drug: Implantable gestrinone
Patients will receive the medication to be administered orally at 2mg daily for 12 months.
Drug: Oral Dienogest
1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
Also known as: Gestrinone pellet
Administered orally at 2 mg daily
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, 6 and 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Pre-treatment, 3 , 6 and 12 months
Plan to share: No — The patients data will be reported together in the final report.
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