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Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis

NCT03481842 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-10-29

No results posted yet for this study

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

Conditions

  • Endometriosis
  • Endometriosis Ovary
  • Endometriosis Externa
  • Endometriosis, Rectum

Interventions

BIOLOGICAL

Linifanib

in a minimally sufficient therapeutic dose

DRUG

BIBW2992

in a minimally sufficient therapeutic dose

DRUG

Axitinib

in a minimally sufficient therapeutic dose

Sponsors & Collaborators

  • BioGene Pharmaceutical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-10
Primary Completion
2021-10-10
Completion
2021-10-10

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481842 on ClinicalTrials.gov