NCT06398145

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 23, 2024

Last Update Submit

April 30, 2024

Conditions

Abnormal Uterine Bleeding

Outcome Measures

Primary Outcomes (1)

  • AUB

    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 Outcomes (8)

  • Serum level of Estradiol

    0, 3 and 6 months

  • Serum level of Estrone

    0, 3 and 6 months

  • Serum level of Testosterone

    0, 3 and 6 months

  • Serum level of Androstenedione

    0, 3 and 6 months

  • Serum level of Total cholesterol

    0, 3 and 6 months

  • +3 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

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)Dietary Supplement: D-chiro-inositol and lactalbumin (low dose)

Interventions

D-chiro-inositol and lactalbumin (high dose)DIETARY_SUPPLEMENT

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

Treatment
D-chiro-inositol and lactalbumin (low dose)DIETARY_SUPPLEMENT

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

Treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • AUB

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Metrorrhagia

Interventions

Lactalbumin

Condition Hierarchy (Ancestors)

Uterine HemorrhageUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlbuminsProteinsAmino Acids, Peptides, and ProteinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2024

First Posted

May 3, 2024

Study Start

June 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

May 3, 2024

Record last verified: 2024-04