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NCT06398145 Clinical Trial

D-chiro-inositol and AUB

Abnormal Uterine Bleeding Clinical Trial

Official title:
The Use of D-chiro-inositol in the Treatment of AUB

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06398145
Other study ID # INOSENDO
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 1, 2024
Est. completion date July 1, 2025

Study information
Verified date April 2024
Source University Of Perugia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with AUB will undergo 6-month treatment with D-chiro-inositol and will fill in questionnaires on AUB, with the evaluation of hormonal serum levels.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date July 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - AUB Exclusion Criteria: - Menopause - Cancer diagnosis - Atypical endometrial hyperplasia - Uterine fibroids - Heavy symptoms requiring pharmacological intervention - Progestogens treatment in the six months before the study - Inositol treatment in the six months before the study

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• D-chiro-inositol and lactalbumin (high dose)
From 0 to 3 months: 1200mg D-chiro-inositol and 120mg lactalbumin per day
• D-chiro-inositol and lactalbumin (low dose)
From 3 to 6 months: 600mg D-chiro-inositol and 60mg lactalbumin per day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Of Perugia

Outcome
Type Measure Description Time frame Safety issue
Primary AUB The "Menstrual Bleeding Questionnaire", a standardized and validated questionnaire, will be administered to patients to evaluate te extent of AUB and the impact on their quality of life. 0, 3 and 6 months
Secondary Serum level of Estradiol Serum levels of estradiol will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of Estrone Serum levels of estrone will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of Testosterone Serum levels of testosterone will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of Androstenedione Serum levels of androstenedione will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of Total cholesterol Serum levels of total cholesterol will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of High-Density Lipoprotein Serum levels of HDL will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of Low-Density Lipoprotein Serum levels of LDL will be evaluated after intravenous blood sampling 0, 3 and 6 months
Secondary Serum level of Triglyceride Serum levels of triglyceride will be evaluated after intravenous blood sampling 0, 3 and 6 months
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