Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment
Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
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.