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

NCT06543550 | Recruiting Phase 4

• 1 other identifier: CS.001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Endometriosis

Keywords

Endometriosis; Implantable Gestrinone; Dienogest

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Evaluation of quality of life

  Pre-treatment, 6 and 12 months

• Evaluation of adverse effect

  Pre-treatment, 1 week, 1, 3 , 6 and 12 months

• Evaluation of abnormal Uterine Bleeding (AUB)

  Pre-treatment, 1, 3 , 6 and 12 months

• Evaluation of sexual function

  Pre-treatment, 1 week, 1, 3 , 6 and 12 months

• Evaluation of body composition

  Pre-treatment, 3 , 6 and 12 months

Study Arms (2)

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.

Drug: Implantable gestrinone

Oral Dienogest

ACTIVE COMPARATOR

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

Drug: Oral Dienogest

Interventions

Implantable gestrinone DRUG

1.6mg/kg of weight of gestrinone in pellets (bio meds Brasil, Florianópolis, Brazil) subcutaneously, in the gluteal region.

Also known as: Gestrinone pellet

Implantable Gestrinone

Oral Dienogest DRUG

Administered orally at 2 mg daily

Oral Dienogest

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio Meds Pharmaceutica Ltda: lead

Study Sites (4)

Gm Ignacio Atividade Medica LTDA

Brasília, Federal District, 70.390-150, Brazil

RECRUITING

Instituto Longevite Servicos Medicos LTDA

Campina Grande, Paraíba, 58.400-506, Brazil

RECRUITING

Jpml Clinica Medica LTDA

São José dos Campos, São Paulo, 12.246-876, Brazil

RECRUITING

Dra Juliana Bicca Endocrinologia e Medicina Funcional LTDA

São Paulo, 05.688-021, Brazil

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

dienogest

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

André V. A. Florentino, Dr

CONTACT

+55 83 982001868; f.andrevinicius@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 9, 2024
• Study Start: July 30, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (4)