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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&#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<0.05.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable Gestrinone | Experimental | 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. |
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| Oral Dienogest | Active Comparator | Patients will receive the medication to be administered orally at 2mg daily for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable gestrinone | Drug | 1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| André V. A. Florentino, Dr | Contact | +55 83 982001868 | f.andrevinicius@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gm Ignacio Atividade Medica LTDA | Recruiting | Brasília | Federal District | 70.390-150 | Brazil |
The patients data will be reported together in the final report.
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C023635 | dienogest |
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| Oral Dienogest | Drug | Administered orally at 2 mg daily |
|
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 |
| Instituto Longevite Servicos Medicos LTDA | Recruiting | Campina Grande | Paraíba | 58.400-506 | Brazil |
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| Jpml Clinica Medica LTDA | Recruiting | São José dos Campos | São Paulo | 12.246-876 | Brazil |
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| Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA | Recruiting | São Paulo | 05.688-021 | Brazil |
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| D000091662 | Genital Diseases |