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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2021-10-10

Brief Summary

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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

Detailed Description

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The composition of the endometrium includes epithelial cell layers lining the uterine cavity, and deeper stroma, including the secretory glands. Each layer is characterized by the presence of a large number of blood vessels, through which a sufficient amount of blood is delivered. A large number of these vessels and arteries go to the surface layers due to myometrium and form a capillary network in the stroma.

In the vaginal suppositories, the investigators applied minimally therapeutic doses of inhibitors of neoangiogenesis, as well as other components that caused the pathological growth of the endometrium.

Anti-angiogenic therapy - inhibition of proliferative processes in the vascular wall of capillaries and small vessels in the endometrium, is the determining factor of the therapeutic effect of endometriosis when treated with vaginal suppositories.

The composition of the suppository:

* Axitinib, Afatinib, Linifanib (ABT-869) in a minimally sufficient therapeutic doses
* Auxiliary substances that ensure a uniform release of active components from suppositories, taking into account the dependence of this process on the chemical nature of the basis, surfactant, dissolution medium.

(the composition and amount of excipients are maximally optimal for bioavailability of drugs from suppositories, taking into account the pharmacokinetics, pharmacodynamics and synergy of active drugs) This therapy has a slight teratogenic effect, which should be taken into account when planning pregnancy.

Conditions

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Endometriosis Endometriosis Ovary Endometriosis Externa Endometriosis, Rectum

Keywords

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Endometriosis VEGF(R)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single application in the morning of a vaginal suppository ELTA:

Five days per week (with a treatment-free interval of two days in a row.) e.g. Monday and Tuesday - treatment-free days.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaginal Suppositories

Daily single administration of vaginal suppository in diagnosed endometriosis. Duration of admission-five days, two days-off. The total duration of treatment is 6 weeks. General course -30 vaginal suppositories ELTA

The composition of the suppository:

* Axitinib (inhibitor of VEGFR1, VEGFR2, VEGFR3, PDGFRβ and c-Kit) in a minimally sufficient therapeutic dose
* Afatinib (BIBW2992) EGFR / HER2 including EGFR (wt), EGFR (L858R), EGFR (L858R / T790M) and HER2 inhibitor - minimally sufficient therapeutic dose
* Linifanib (ABT-869) ATP-competitive VEGFR / PDGFR inhibitor for KDR, CSF-1R, Flt-1/3 and PDGFRβ - minimally sufficient therapeutic dose

Group Type EXPERIMENTAL