D-chiro-inositol and AUB

The Use of D-chiro-inositol in the Treatment of AUB

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06398145

Enrollment

Registered

2024-05-03

Start date

2024-06-01

Completion date

2025-07-01

Last updated

2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Uterine Bleeding

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.

Interventions

DIETARY_SUPPLEMENTD-chiro-inositol and lactalbumin (high dose)

From 0 to 3 months: 1200mg D-chiro-inositol and 120mg lactalbumin per day

DIETARY_SUPPLEMENTD-chiro-inositol and lactalbumin (low dose)

From 3 to 6 months: 600mg D-chiro-inositol and 60mg lactalbumin per day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Serum level of Estrone	0, 3 and 6 months	Serum levels of estrone will be evaluated after intravenous blood sampling
Serum level of Testosterone	0, 3 and 6 months	Serum levels of testosterone 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 Estradiol	0, 3 and 6 months	Serum levels of estradiol 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 Low-Density Lipoprotein	0, 3 and 6 months	Serum levels of LDL 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 Total cholesterol	0, 3 and 6 months	Serum levels of total cholesterol will be evaluated after intravenous blood sampling

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026