Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment
Brazil100 participantsStarted 2023-02-13
Plain-language summary
Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet. PK profile of the gestrinone pellet will be monitored.
Who can participate
Age range18 Years ā 50 Years
SexFEMALE
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Inclusion criteria
ā. Willingness to provide informed consent
ā. Woman aged between 18 and 50 years
ā. Body weight between 50 Ā± 5 kg and 90 Ā± 5 kg
ā. Pelvic pain secondary to endometriosis surgically treated with refractory symptoms, independent of pain intensity
ā. Deep infiltrative endometriosis documented by biopsies (histopathological examination)
ā. Last endometriosis surgery at least 3 months before randomization
ā. Not planning to become pregnant within 12 months after the screening visit or be surgically sterilized
ā. Absence of changes in the breast (BI-RADS1 and BIRADS-2 classification) documented by an imaging report (mammogram for women aged \> 40 years or bilateral breast ultrasound for women aged \< 40 years) performed less than 12 months before randomization
Exclusion criteria
ā. Chronic severe disorders, including metastatic malignancies, end-stage renal disease with or without dialysis, clinically unstable heart disease, or any other disorder that, in the opinion of the investigator, excludes the participant from the study
What they're measuring
1
Combination of serious adverse events (SAEs) accumulated within 6 months of gestrinone or placebo pellet insertion and collected through spontaneous reporting and/or clinical findings
Timeframe: From randomization to the end of study on Day 180
ā. Suspected or confirmed diagnosis of immunodeficiency based on medical history and/or physical or laboratory examination
ā. Other medical or psychiatric conditions, including recent laboratory abnormalities (within the last 12 months) that may increase risks to the study participant or, at the discretion of the investigator, make the participant inappropriate for the study
ā. Personal history of thromboembolic events
ā. Use anticoagulant medication
ā. Contraindication to the use of hormonal contraceptives