D-chiro-inositol and AUB

April 30, 2024 updated by: Sandro Gerli, University Of Perugia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: D-chiro-inositol and lactalbumin (high dose)
From 0 to 3 months: 1200mg D-chiro-inositol and 120mg lactalbumin per day
Dietary supplement: D-chiro-inositol and lactalbumin (low dose)
From 3 to 6 months: 600mg D-chiro-inositol and 60mg lactalbumin per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUB
Time Frame: 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.
0, 3 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INOSENDO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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