Evaluation of the effect exerted by the activated form of folic acid and not activated folic acid in postmenopausal wome

• Conditions: The study evaluates the effects of different forms of folates on cardiovascular risk factors in postmenopausal patients; MedDRA version: 14.1Level: PTClassification code 10051775Term: PostmenopauseSystem Organ Class: 10041244 - Social circumstances; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-005666-37-IT
• Lead Sponsor: ZAMBON ITALIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-12
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Postmenopausal women with age between 45 and 55 at screening; - Women with plasmatic folate levels not superior than 5 ng/ml as assessed in the screening visit; -Women who have no intention of taking hormone replacement therapy -; -BMI between 19 and 30; -Good physical health and mental health; -Willingness to sign the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Severe hypertension therapy. -Patients who smoke -Presence or history of significant liver disease until the liver function tests are not back to normal; -Presence or history of liver tumors (benign or malignant); -Malignant neoplasms, known or suspected; -Hypersensitivity to the active substance or excipients of the drug under study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified