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

• Status: Withdrawn
• Trial end date: 2021-10-10
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioGene Pharmaceutical Ltd.
• Treatments: Afatinib; Axitinib

Criteria

Inclusion Criteria:

• verification of endometriosis

• signed agreement of informed consent

• agreement with information on the nature, relevance and scope of the investigation, as well as the expected results and undesirable consequences of IMD

Exclusion Criteria:

• use of not permitted contraception or not willing to use contraception

• pregnancy or lactation

• planned pregnancy in the next 36 months with the consent to participate in that clinical trial

• use of any other intravaginal medicinal product or medical device

• known hypersensitivity to one or more of the active and / or inactive ingredients

• acute or chronic renal failure

• acute or chronic heart failure

• the patient's reluctance to follow the trial protocol

• chronic alcoholism

• drug addiction

• use of antidepressants (during participation in trial)