D-chiro-inositol and AUB

Phase 2

Not yet recruiting

• Conditions: Abnormal Uterine Bleeding
• Interventions: Dietary Supplement: D-chiro-inositol and lactalbumin (high dose); Dietary Supplement: D-chiro-inositol and lactalbumin (low dose)

• Registration Number: NCT06398145
• Lead Sponsor: University Of Perugia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Study Start: 2024-06-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• AUB

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	D-chiro-inositol and lactalbumin (low dose)	Patients will undergo 3 months treatment with 1200 mg D-chiro-inositol and 120 mg lactalbumin, than 3 months treatment with 600 mg D-chiro-inositol and 60 mg lactalbumin
Treatment	D-chiro-inositol and lactalbumin (high dose)	Patients will undergo 3 months treatment with 1200 mg D-chiro-inositol and 120 mg lactalbumin, than 3 months treatment with 600 mg D-chiro-inositol and 60 mg lactalbumin

Primary Outcome Measures

Name	Time	Method
AUB	0, 3 and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Serum level of Testosterone	0, 3 and 6 months	Serum levels of testosterone will be evaluated after intravenous blood sampling
Serum level of High-Density Lipoprotein	0, 3 and 6 months	Serum levels of HDL will be evaluated after intravenous blood sampling
Serum level of Estradiol	0, 3 and 6 months	Serum levels of estradiol will be evaluated after intravenous blood sampling
Serum level of Estrone	0, 3 and 6 months	Serum levels of estrone will be evaluated after intravenous blood sampling
Serum level of Androstenedione	0, 3 and 6 months	Serum levels of androstenedione will be evaluated after intravenous blood sampling
Serum level of Total cholesterol	0, 3 and 6 months	Serum levels of total cholesterol will be evaluated after intravenous blood sampling
Serum level of Triglyceride	0, 3 and 6 months	Serum levels of triglyceride will be evaluated after intravenous blood sampling
Serum level of Low-Density Lipoprotein	0, 3 and 6 months	Serum levels of LDL will be evaluated after intravenous blood sampling