EndometriosisPhase 4NCT06543550
Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis
A Phase 4 study testing Implantable gestrinone and Oral Dienogest in people with Endometriosis, run by Bio Meds Pharmaceutica Ltda at 4 sites in Brazil.
Trial summary
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Implantable gestrinone and Oral Dienogest
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesBrazil
- Study dates
- 30 Jul 2024to Mar 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil4 sites, 4 recruiting
- Recruiting
Instituto Longevite Servicos Medicos LTDA
Campina Grande, Paraíba, 58.400-506
André V.A. Florentino, Dr, +55 83 3077-8928, f.andrevinicius@gmail.com
f.andrevinicius@gmail.com V.A. Florentino, Dr
- Recruiting
Nutrindo Ideiais Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Guilherme Renke Renke, Dr, +55 21 994431653, renke@renke.com.br
- Recruiting
Jpml Clinica Medica LTDA
São José dos Campos, São Paulo, 12.246-876
Juliana P.M. Lima, Dr, +55 12 3939-6436, drajulianapaola@gmail.com
Juliana P.M. Lima, Dr
- Recruiting
Nutrindo Ideiais São Paulo
São Paulo, São Paulo
Guilherme Renke Renke, Dr, +55 21 994431653, renke@renke.com.br
About this study
Official title: Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial
This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.
Read the 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\&#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.
- Conditions
- Endometriosis
- Being tested
- Implantable gestrinone, Oral Dienogest
- Keywords
- Endometriosis, Implantable Gestrinone, Dienogest
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable gestrinoneDrug
Also called Gestrinone pellet
1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.
Oral DienogestDrug
Administered orally at 2 mg daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Implantable gestrinone |
| Oral Dienogest | Active comparator | Patients will receive the medication to be administered orally at 2mg daily for 12 months. Receives: Drug: Oral Dienogest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, 6 and 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Pre-treatment, 3 , 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Jul 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio Meds Pharmaceutica Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543550
- Sponsor's protocol ID
- CS.001
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patients data will be reported together in the final report.