Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
Status:
Withdrawn
Trial end date:
2021-10-10
Target enrollment:
Participant gender:
Summary
Background:
Endometriosis is a chronic gynecological disease with the growth of endometrial tissue
outside the endometrium. In all its properties, this tissue is similar to the mucous membrane
of the uterus.
Types of endometriosis:
Endometriosis is divided into genital and extragenital. Genital endometriosis is internal and
external. When the inner is affected by the uterus, with the external - the ovaries, tubes,
vagina and external genital organs are affected. Extragenital endometriosis can affect
various organs of the abdominal cavity.
Drug treatment does not show high effectiveness. Surgery / laparoscopic is currently
considered the gold standard treatment for this problem, including infertility treatment.
The purpose of our studies is to achieve substantial results with respect to tolerability,
safety and clinical efficacy of vaginal suppository ELTA for treatment of the endometriosis.
Methods:
Phase I clinical trial to be conducted at Cancer Center to hold under the aegis
UniversitätsSpital Zürich from May 2018 to September 2018.
Ninety-four patients with the form of genital endometriosis will take part in the studies.
The study was approved by the Ethics Committee at the Cancer Institute no C99884.01FH339