Polycystic Ovary SyndromeNCT03673995
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
A study testing Myo-inositol+L-tyrosine in people with Polycystic Ovary Syndrome and Menstrual Problem, run by Pharmarte srl at 1 site in Italy.
Trial summary
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Read more about this study
- Who is it for?
- Ages 16 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Menstrual Problem, Hirsutism
- What is being tested?
- Myo-inositol+L-tyrosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2017to 30 Oct 2018
- Phase
- Interventional
- 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 16 to 38 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- ° PCOS patients
Who cannot join
- thyroid dysfunction
- hyperprolactinemia
- adrenal hyperplasia
- patients taking oral contraceptive
- any other endocrinological pathologies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.
- Conditions
- Polycystic Ovary Syndrome, Menstrual Problem, Hirsutism
- Being tested
- Myo-inositol+L-tyrosine
- Medical subject headings
- Polycystic Ovary Syndrome, Menstruation Disturbances, Hirsutism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol+L-tyrosineDietary supplement
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.
| Study group | Role | What they receive |
|---|---|---|
| Myo-inositol+L-tyrosine | Experimental | One sachet per day containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid for improving PCOS symptoms. Receives: Dietary Supplement: Myo-inositol+L-tyrosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restore of regular menstrual period
Self report
Measured: 6 months of treatment
Secondary outcomes (2)
Improving hirsutism
Standardised visual scales are preferred when assessing hirsutism, such as the modified Ferriman Gallwey score (mFG) with a level ≥ 4 - 6 indicating hirsutism,
Measured: 6 months of treatment
Restore ovulation
Progesterone value in luteal phase
Measured: 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start2 May 2017
- Primary completion22 Aug 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmarte srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Montanino Oliva, M.D., Principal investigator, Altamedica Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673995
- Sponsor's protocol ID
- PharmarteLtyrosine1
- Status last verified
- Sep 2018
- First submitted
- 22 Aug 2018
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS Women
- ClinicalTrials.gov ID
- NCT03673995
- Acronym / sponsor ID
- PharmarteLtyrosine1
- Conditions
- Polycystic Ovary Syndrome, Menstrual Problem, Hirsutism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Pharmarte srlIndustry (pharma, biotech, devices)
- Study start
- 2 May 2017 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 17 Sep 2018 (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.
PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation , hirsutism scoring and ovulation assesment. Most of them during the treatment improved their symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myo-inositol+L-tyrosine | Experimental | Dietary Supplement: Myo-inositol+L-tyrosineOne sachet per day containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid for improving PCOS symptoms. |
Who may qualify
- Ages
- 16 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- ° PCOS patients
Key exclusion criteria (5 listed)
- thyroid dysfunction
- hyperprolactinemia
- adrenal hyperplasia
- patients taking oral contraceptive
- any other endocrinological pathologies
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 |
|---|---|---|
| Myo-inositol+L-tyrosinePCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment. | Dietary supplement | Myo-inositol+L-tyrosine |
Primary outcome
Restore of regular menstrual period
Time frame: 6 months of treatment
Self report
2 secondary outcomes
Improving hirsutism
Time frame: 6 months of treatment
Restore ovulation
Time frame: 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
Mario Montanino Oliva, M.D. principal investigator
Altamedica Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-inositol+L-tyrosine in people with Polycystic Ovary Syndrome and Menstrual Problem, run by Pharmarte srl at 1 site in Italy.
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 5 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: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Restore of regular menstrual period (time frame: 6 months of treatment). 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 16 Jun 2020.