Abnormal Uterine BleedingPhase 2NCT06398145
D-chiro-inositol and AUB
A Phase 2 study testing D-chiro-inositol and lactalbumin (high dose) and D-chiro-inositol and lactalbumin (low dose) in people with Abnormal Uterine Bleeding, run by University Of Perugia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- D-chiro-inositol and lactalbumin (high dose) and D-chiro-inositol and lactalbumin (low dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- AUB
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Abnormal Uterine Bleeding
- Being tested
- D-chiro-inositol and lactalbumin (high dose), D-chiro-inositol and lactalbumin (low dose)
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: D-chiro-inositol and lactalbumin (high dose); Dietary Supplement: D-chiro-inositol and lactalbumin (low dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3 and 6 months
Secondary outcomes (8)
Serum level of Estradiol
Serum levels of estradiol will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of Estrone
Serum levels of estrone will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of Testosterone
Serum levels of testosterone will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of Androstenedione
Serum levels of androstenedione will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of Total cholesterol
Serum levels of total cholesterol will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of High-Density Lipoprotein
Serum levels of HDL will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of Low-Density Lipoprotein
Serum levels of LDL will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Serum level of Triglyceride
Serum levels of triglyceride will be evaluated after intravenous blood sampling
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandro Gerli, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398145
- Sponsor's protocol ID
- INOSENDO
- Status last verified
- Apr 2024
- First submitted
- 23 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of D-chiro-inositol in the Treatment of AUB
- ClinicalTrials.gov ID
- NCT06398145
- Acronym / sponsor ID
- INOSENDO
- Conditions
- Abnormal Uterine Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- AUB
Key exclusion criteria (7 listed)
- Menopause
- Cancer diagnosis
- Atypical endometrial hyperplasia
- Uterine fibroids
- Heavy symptoms requiring pharmacological intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-chiro-inositol and lactalbumin (high dose)From 0 to 3 months: 1200mg D-chiro-inositol and 120mg lactalbumin per day | Dietary supplement | Treatment |
| D-chiro-inositol and lactalbumin (low dose)From 3 to 6 months: 600mg D-chiro-inositol and 60mg lactalbumin per day | Dietary supplement | Treatment |
Primary outcome
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.
8 secondary outcomes
Serum level of Estradiol
Time frame: 0, 3 and 6 months
Serum level of Estrone
Time frame: 0, 3 and 6 months
Serum level of Testosterone
Time frame: 0, 3 and 6 months
Serum level of Androstenedione
Time frame: 0, 3 and 6 months
Serum level of Total cholesterol
Time frame: 0, 3 and 6 months
Serum level of High-Density Lipoprotein
Time frame: 0, 3 and 6 months
Serum level of Low-Density Lipoprotein
Time frame: 0, 3 and 6 months
Serum level of Triglyceride
Time frame: 0, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing D-chiro-inositol and lactalbumin (high dose) and D-chiro-inositol and lactalbumin (low dose) in people with Abnormal Uterine Bleeding, run by University Of Perugia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUB (time frame: 0, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.