Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis (NCT03481842) | Clinical Trial Compass
WithdrawnPhase 1/2
Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
Stopped: Change in study design and sponsor
Switzerland0Started 2021-10-10
Plain-language 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
Who can participate
Age range
19 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Local tolerability of the vaginal suppository ELTA defined as a cumulative sum of clinical signs for each patient