NCT03481842: ELTA

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

Withdrawn Phase 1, PHASE2 Last updated 29 October 2021

What this trial tests

Phase 1, PHASE2 trial testing Linifanib in Endometriosis. Withdrawn.

Timeline

10 October 2021

Primary endpoint
10 October 2021

10 October 2021

Quick facts

Lead sponsor	BioGene Pharmaceutical Ltd.
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Start date	10 October 2021
Primary completion	10 October 2021
Estimated completion	10 October 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• Linifanib — full drug profile →
• BIBW2992 — full drug profile →
• Axitinib — full drug profile →

Conditions studied

• Endometriosis — all drugs for Endometriosis →
• Endometriosis Ovary — all drugs for Endometriosis Ovary →
• Endometriosis Externa — all drugs for Endometriosis Externa →
• Endometriosis, Rectum — all drugs for Endometriosis, Rectum →

Sponsor

BioGene Pharmaceutical Ltd.

Who can join

Adults 19 to 60, female only, with Endometriosis or Endometriosis Ovary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impacts of endometrioma on ovarian aging from basic science to clinical management.
   Tan Z, Gong X, Li Y, Hung SW, et al · · 2022 · cited 9× · PMID 36686440 · DOI 10.3389/fendo.2022.1073261