Polycystic Ovary SyndromeNCT02651636
Combined Therapy With Myo-inositol and Alpha-Lipoic Acid in PCOS Women
A study testing myo-inositol,alpha-lipoic acid and folic acid in people with Polycystic Ovary Syndrome and Menstrual Pattern, run by Catholic University of the Sacred Heart.
Trial summary
The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Menstrual Pattern, Hyperandrogenism
- What is being tested?
- myo-inositol,alpha-lipoic acid and folic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jul 2015
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PCOS in accordance with Rotterdam criteria
Who cannot join
- pregnancy
- past history of cardiovascular disease,
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test),
- hypertension,
- significant liver or renal impairment,
- other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs),
- neoplasms,
- unstable mental illness.
About this study
Official title: Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome
The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.
- Being tested
- myo-inositol,alpha-lipoic acid and folic acid
- Medical subject headings
- Polycystic Ovary Syndrome, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myo-inositol,alpha-lipoic acid and folic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | Therapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months Receives: Drug: myo-inositol,alpha-lipoic acid and folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cycles in six months of therapy
Measured: 6 months
Secondary outcomes (4)
Hirsutism
Ferriman Gallwey score
Measured: 6 months
Hyperandrogenism
Testosterone, Androstenedione, free androgen index
Measured: 6 months
Insulin response to oral glucose tolerance test
Measured: 6 months
Lipidic profile
Total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionJul 2015
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosanna Apa, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651636
- Sponsor's protocol ID
- 000102014
- Status last verified
- Jan 2016
- First submitted
- 27 Nov 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Therapy With Myo-inositol and Alpha-Lipoic Acid on Clinical, Endocrine and Metabolic Features in Women Affected by Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02651636
- Acronym / sponsor ID
- 000102014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- First posted
- 11 Jan 2016 (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.
The aim of our study is to investigate the effects of a combined treatment of alpha-lipoic acid and myoinositol on clinical, endocrine and metabolic features of women affected by PCOS. The study Group included 40 patients treated with a combined therapy of alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months. The investigation includes menstrual pattern, hirsutism score, hormonal assays, oral glucose tolerance test, lipidic profile at baseline and after six months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Drug: myo-inositol,alpha-lipoic acid and folic acidTherapy with alpha-lipoic acid (800 mg), myoinositol (2000 mg) and folic acid (400 mcg) daily for six months |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with PCOS in accordance with Rotterdam criteria
Key exclusion criteria (8 listed)
- pregnancy
- past history of cardiovascular disease,
- diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 g oral glucose tolerance test),
- hypertension,
- significant liver or renal impairment,
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,alpha-lipoic acid and folic acid | Drug | Open label |
Primary outcome
Number of cycles in six months of therapy
Time frame: 6 months
4 secondary outcomes
Hirsutism
Time frame: 6 months
Hyperandrogenism
Time frame: 6 months
Insulin response to oral glucose tolerance test
Time frame: 6 months
Lipidic profile
Time frame: 6 months
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 11 Jan 2016.
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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 study testing myo-inositol,alpha-lipoic acid and folic acid in people with Polycystic Ovary Syndrome and Menstrual Pattern, run by Catholic University of the Sacred Heart.
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 8 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 11 Jan 2016. 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.
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?
Number of cycles in six months of therapy (time frame: 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 11 Jan 2016.