Not provided
Not provided
Not provided
Not provided
Change in study design and sponsor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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:
(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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Suppositories | Experimental | 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linifanib | Biological | in a minimally sufficient therapeutic dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability of the vaginal suppository ELTA defined as a cumulative sum of clinical signs for each patient | Local tolerability of the vaginal suppositories ELTA will be defined as a cumulative sum score of the solicited local /vaginal (consisting of subjectively experienced symptoms rated by the patient: burning, itching, bleeding, pain, dryness and objectively documented findings rated by the physician: redness, petechial bleeding, dryness, swelling) for each patient after every weeks of application (scored from 0 [none/normal] to 5 [severe]) Weekly visit of patients every seventh day from the beginning of treatment. SCALE EVALUATION EVENTS
If there is bleeding or the development of edema - the study for the patient will be stopped. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective symptoms (local tolerability) | Each of the subjective symptoms (scored from 0 [none/normal] to 5 [severe]) from the first visit (after the first application)/ A detailed description of the symptoms in each visit (with endoscopic photofixation of the endometriosis surface) | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective findings | Each of the objective symptoms (scored from 0 [none/normal] to 3 [severe]) from the first visit (after the first application).
A detailed description of the symptoms in each visit (with endoscopic photofixation of the endometriosis surface) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioGene Pharmaceutical Ltd. | Basel | Вâlе | 4057 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C513486 | linifanib |
| D000077716 | Afatinib |
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| BIBW2992 | Drug | in a minimally sufficient therapeutic dose |
|
|
| Axitinib | Drug | in a minimally sufficient therapeutic dose |
|
|
| 7 weeks |
| Global judgement of tolerability | Global judgement of tolerability by investigator and patients. The scores of the Clinical Global Impression (CGI) Scale. | 4 weeks |
| Safety evaluation of therapy | Safety evaluation of therapy. Drugs safety will be evaluated by assessment of adverse events ( ADRs). | 15 weeks |
| Serious Adverse Event. | Occurrence of AE / SAE / ADE / SADE. Characteristics of occured AE / SAE / ADE / SADE | up to 15 weeks |
| Change in pH-value from vaginal smear | pH-value from vaginal smear at every visit for each patient after the 3rd and 6th week of application of suppositories. | up to 6 weeks |
| Change in Vaginal flora | Vaginal flora (Lactobacillus spp., Atopobium vaginae and Gardnerella vaginalis) on the first day of intake (before using the first suppository) and on the day of termination of therapy | up to 15 weeks |
| Other signs of assessing the hip therapy | Mandatory Clinical blood test for each patient after the 3rd and 6th week of application of suppositories. A control blood test on the first day of the 15th week after the start of the first suppository | up to 15 weeks |
| D000091662 | Genital Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001549 | Benzamides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |