PCOSPhase 4NCT01514942
Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
A Phase 4 study testing Myo-inositol + Folic acid, D-chiro-inositol, manganese, folic acid, vit B12 and Folic acid, vit B12 in people with PCOS, run by AGUNCO Obstetrics and Gynecology Centre at 1 site in Italy.
Trial summary
Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- Myo-inositol + Folic acid, D-chiro-inositol, manganese, folic acid, vit B12 and Folic acid, vit B12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women fulfilled two out of three diagnostic criteria for PCOS
Who cannot join
- Women with pre-existing secondary endocrine disorders
- Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
- Women who received treatment with other drugs for the previous 6 months before entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.
Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.
Read more
In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.
In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.
- Conditions
- PCOS
- Being tested
- Myo-inositol + Folic acid, D-chiro-inositol, manganese, folic acid, vit B12, Folic acid, vit B12
- Keywords
- PCOS, Insulin resistance, Myo-inositol, D-chiro-inositol
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-inositol + Folic acidDietary supplement
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
Myo-inositol + Folic acidDietary supplement
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
D-chiro-inositol, manganese, folic acid, vit B12Dietary supplement
D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
D-chiro-inositol, manganese, folic acid, vit B12Dietary supplement
D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Folic acid, vit B12Drug
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Folic acid, vit B12Drug
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
| Study group | Role | What they receive |
|---|---|---|
| Insulin resistant patients | Other | Not described Receives: Dietary Supplement: Myo-inositol + Folic acid; Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12; Drug: Folic acid, vit B12 |
| Non-insulin resistant patients | Other | Not described Receives: Dietary Supplement: Myo-inositol + Folic acid; Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12; Drug: Folic acid, vit B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
Menstrual cycle
Score acne (acne grading system by Cremoncini et al)
Score hirsutism (Ferriman-Gallwey score)
Alopecia
Oral Glucose Tolerance Test (OGTT)
Glucagon levels
C-peptide test
Myo-inositol serum concentration
D-chiro-inositol serum concentration
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Prolactin (PRL) levels test
Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Total and free testosterone levels
Sex hormone binding globulin (SHBG) test
17-Hydroxyprogesterone (17-OHP) levels
Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
delta 4-androstenedione levels
progesterone levels
Adrenocorticotropic Hormone (ACTH) stimulation test
Ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Antral follicle counts
Stromal/Cortical ratio in the ovary
Endometrial thickness
Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies 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 4
Sponsor and investigators
- Lead sponsor
- AGUNCO Obstetrics and Gynecology Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514942
- Sponsor's protocol ID
- MIvsDCI_PCOS/IR
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 23 Jan 2012
- Results posted
- No
Publications
Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.
PubMed 19499845Raffone E, Rizzo P, Benedetto V. Insulin sensitiser agents alone and in co-treatment with r-FSH for ovulation induction in PCOS women. Gynecol Endocrinol. 2010 Apr;26(4):275-80. doi: 10.3109/09513590903366996.
PubMed 20222840Larner J. D-chiro-inositol--its functional role in insulin action and its deficit in insulin resistance. Int J Exp Diabetes Res. 2002;3(1):47-60. doi: 10.1080/15604280212528.
PubMed 11900279Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.
PubMed 20811656
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
- ClinicalTrials.gov ID
- NCT01514942
- Acronym / sponsor ID
- MIvsDCI_PCOS/IR
- Conditions
- PCOS
- Keywords
- PCOS, Insulin resistance, Myo-inositol, D-chiro-inositol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AGUNCO Obstetrics and Gynecology CentreUniversity, hospital or other
- First posted
- 23 Jan 2012 (estimated)
- 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.
Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.
Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug.
In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported.
In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin resistant patients | Other | Dietary Supplement: Myo-inositol + Folic acid, Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12, Drug: Folic acid, vit B12 |
| Non-insulin resistant patients | Other | Dietary Supplement: Myo-inositol + Folic acid, Dietary Supplement: D-chiro-inositol, manganese, folic acid, vit B12, Drug: Folic acid, vit B12 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women fulfilled two out of three diagnostic criteria for PCOS
Key exclusion criteria (3 listed)
- Women with pre-existing secondary endocrine disorders
- Women with personal history of hypertension, diabetes mellitus or cardiovascular disorders
- Women who received treatment with other drugs for the previous 6 months before entering the study.
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 + Folic acidMyo-inositol (2g) Folic acid (200mcg) (2 per day) | Dietary supplement | Insulin resistant patients |
| Myo-inositol + Folic acidMyo-inositol (2g) Folic acid (200mcg) (2 per day) | Dietary supplement | Non-insulin resistant patients |
| D-chiro-inositol, manganese, folic acid, vit B12D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) | Dietary supplement | Insulin resistant patients |
| D-chiro-inositol, manganese, folic acid, vit B12D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) | Dietary supplement | Non-insulin resistant patients |
| Folic acid, vit B12Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) | Drug | Insulin resistant patients |
| Folic acid, vit B12Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day) | Drug | Non-insulin resistant patients |
Primary outcome
Body Mass Index (BMI)
Menstrual cycle
Score acne (acne grading system by Cremoncini et al)
Score hirsutism (Ferriman-Gallwey score)
Alopecia
Oral Glucose Tolerance Test (OGTT)
Glucagon levels
C-peptide test
Myo-inositol serum concentration
D-chiro-inositol serum concentration
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Prolactin (PRL) levels test
Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Total and free testosterone levels
Sex hormone binding globulin (SHBG) test
17-Hydroxyprogesterone (17-OHP) levels
Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
delta 4-androstenedione levels
progesterone levels
Adrenocorticotropic Hormone (ACTH) stimulation test
Ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Antral follicle counts
Stromal/Cortical ratio in the ovary
Endometrial thickness
Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.
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 23 Jan 2012.
- Background: PubMed 19499845Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double-blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.
- Background: PubMed 20222840Raffone E, Rizzo P, Benedetto V. Insulin sensitiser agents alone and in co-treatment with r-FSH for ovulation induction in PCOS women. Gynecol Endocrinol. 2010 Apr;26(4):275-80. doi: 10.3109/09513590903366996.
- Background: PubMed 11900279Larner J. D-chiro-inositol--its functional role in insulin action and its deficit in insulin resistance. Int J Exp Diabetes Res. 2002;3(1):47-60. doi: 10.1080/15604280212528.
- Background: PubMed 20811656Larner J, Brautigan DL, Thorner MO. D-chiro-inositol glycans in insulin signaling and insulin resistance. Mol Med. 2010 Nov-Dec;16(11-12):543-52. doi: 10.2119/molmed.2010.00107. Epub 2010 Aug 27.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Myo-inositol + Folic acid, D-chiro-inositol, manganese, folic acid, vit B12 and Folic acid, vit B12 in people with PCOS, run by AGUNCO Obstetrics and Gynecology Centre 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 3 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 23 Jan 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Body Mass Index (BMI). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01514942, which also lists 4 linked publications.
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 23 Jan 2012.