D-chiro-inositol and AUB

NCT ID: NCT06398145

Last Updated: 2024-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-07-01

Brief Summary

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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

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Conditions

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Abnormal Uterine Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

D-chiro-inositol and lactalbumin (high dose)

Intervention Type DIETARY_SUPPLEMENT

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

D-chiro-inositol and lactalbumin (low dose)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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D-chiro-inositol and lactalbumin (high dose)

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

Intervention Type DIETARY_SUPPLEMENT

D-chiro-inositol and lactalbumin (low dose)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Of Perugia

OTHER

Sponsor Role lead

Responsible Party

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Sandro Gerli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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INOSENDO

Identifier Type: -

Identifier Source: org_study_id

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