D-chiro-inositol and AUB

NCT06398145 — Phase 2, Unknown, 20 participants, University Of Perugia

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

Registry	NCT06398145
Status	Unknown
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	20 (Estimated)
Sponsor	University Of Perugia (Other)
Conditions	Abnormal Uterine Bleeding
Interventions	D-chiro-inositol and lactalbumin (high dose), D-chiro-inositol and lactalbumin (low dose) (Dietary supplement)
Dates	start 2024-06-01 (estimated), primary completion 2025-06-01 (estimated), completion 2025-07-01 (estimated), first posted 2024-05-03, last updated 2024-05-03

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment	Experimental	Dietary Supplement: D-chiro-inositol and lactalbumin (high dose); Dietary Supplement: 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

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

+Outcome measures

Primary outcomes

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 outcomes

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 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 Total cholesterol [0, 3 and 6 months]: Serum levels of total cholesterol 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

+Eligibility

Sex: Female, ages: 18 Years to 50 Years

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