Status:
UNKNOWN
Study of the Effects of Cyclodynon on Reducing the Cumulative Risk of Breast Cancer Development in a Female Aged 40-52
Lead Sponsor:
Dr. Struk Tetiana
Collaborating Sponsors:
Bionorica SE
Conditions:
Mammographic Breast Density
Eligibility:
FEMALE
40-52 years
Phase:
PHASE4
Brief Summary
Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded as one of the risk factors for the development of breast cancer in women aged 40 to 52 years, which necessi...
Detailed Description
Hypothesis: Increased mammographic density of mammary gland tissues and hyperprolactinaemia are regarded as one of the risk factors for the development of breast cancer in women aged 40 to 52 years, w...
Eligibility Criteria
Inclusion
- Female patients aged 40 to 52 years (inclusive) with mastodynia and BI-RADS category 3.
- The patient's written informed consent to participate in any study-related procedures.
- According to the Investigator, the patient's ability to comply with all the requirements of the study protocol, i.e. the patient's ability to cooperate adequately.
- Patients who do not have chronic diseases of the cardiovascular system, neuroendocrine system, kidneys, liver, gastrointestinal tract, respiratory system, skin in the decompensation stage.
- Consent to use reliable, evidence-based contraceptive methods (double containing the following types: hormonal, barrier, intrauterine spiral, etc.) throughout the study (from the time of the Informed Consent to Visit 6) .
Exclusion
- Hypersensitivity to the components of the IMP.
- Burdened history of allergies.
- Participation in another clinical study less than 90 days before signing the informed consent form.
- History of cancer.
- Pregnancy or lactation.
- Administration of dopamine agonists, dopamine antagonists, oestrogens and antiestrogens, dopamine.
- Secondary amenorrhoea within 6 months or more.
- Surgical, pharmacological or physiological menopause (except hysterectomy).
- The prolactin level is more than 80 ng/mL.
- Other reasons which make the patient's participation in the study undesirable, according to the Investigator.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04498013
Start Date
July 22 2020
End Date
May 1 2022
Last Update
August 4 2020
Active Locations (1)
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1
Clinical and diagnostics center
Kharkiv, Ukraine, 61057