Status:
WITHDRAWN
Safety, Tolerability and Efficacy of Vaginal Suppositories for Treatment of the Endometriosis
Lead Sponsor:
BioGene Pharmaceutical Ltd.
Conditions:
Endometriosis
Endometriosis Ovary
Eligibility:
FEMALE
19-60 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03481842
Start Date
October 10 2021
End Date
October 10 2021
Last Update
October 29 2021
Active Locations (1)
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1
BioGene Pharmaceutical Ltd.
Basel, Вâlе, Switzerland, 4057