Pre-menopausal Irregular Cycles and BleedingsPhase 2/3NCT01115127
Myo-inositol and Melatonin in Pre-menopausal Women
A Phase 2/3 study testing melatonin, myo-inositol and melatonin plus myo-inositol in people with Pre-menopausal Irregular Cycles and Bleedings, run by University of Messina at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory cycles in pre-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Pre-menopausal Irregular Cycles and Bleedings
- What is being tested?
- melatonin, myo-inositol and melatonin plus myo-inositol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 2/3
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- all pre-menopausal women with irregular cycles and bleedings
Who cannot join
- pre-menopausal women who take hormonal drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myo-inositol and Melatonin in Menopausal Transition. A Prospective, Randomized Trial
The purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Read the detailed description
Melatonin has produced a remarkable significant improvement of thyroid function, positive changes of gonadotropins towards reduced levels, and in some women a re-acquisition of normal menstrual cycle. Furthermore, an abrogation of menopause-related depression, amelioration of hot-flashes and improvement of quality and duration of sleep has been reported.
Myo-inositol is involved in several aspects of human reproduction. Elevated concentrations of myo-inositol in human follicular fluids appear to play a positive function in follicular maturity and provide a marker of good quality oocytes. Nevertheless its positive role in PCOS women is a consequence of a defect in the insulin signalling pathway (inositol-containing phosphoglycan mediators) that seems to be primarily implicated in the pathogenesis of insulin resistance
- Being tested
- melatonin, myo-inositol, melatonin plus myo-inositol
- Keywords
- pre-menopause, melatonin, myo-inositol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDietary supplement
30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
myo-inositolDietary supplement
30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
melatonin plus myo-inositolDietary supplement
30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months
| Study group | Role | What they receive |
|---|---|---|
| myo-inositol | Active comparator | 30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months. Receives: Dietary Supplement: myo-inositol |
| melatonin | Active comparator | 30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months Receives: Dietary Supplement: melatonin |
| melatonin plus myo-inositol | Active comparator | 30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months Receives: Dietary Supplement: melatonin plus myo-inositol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Measured: 12 months
Secondary outcomes (5)
Serum assays of thyroid hormones.
Measured: 12 months
Assays of gonadotropins and estradiol serum levels
Measured: 12 months
Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).
Measured: 12 months
Variation of blood pressure.
Measured: 12 months
Variation of mood, hot flashes, quality of sleep.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-menopausal Irregular Cycles and BleedingsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosario D'anna, University of Messina
- Investigators
- Rosario D'Anna, MD, Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115127
- Sponsor's protocol ID
- Myo-Mela-2010
- Status last verified
- Mar 2012
- First submitted
- 22 Apr 2010
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myo-inositol and Melatonin in Menopausal Transition. A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT01115127
- Acronym / sponsor ID
- Myo-Mela-2010
- Keywords
- pre-menopause, melatonin, myo-inositol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 May 2010 (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 purpose of this study is to determine whether myo-inositol and melatonin, or myo-inositol alone, or melatonin alone, are effective in normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Detailed description
Melatonin has produced a remarkable significant improvement of thyroid function, positive changes of gonadotropins towards reduced levels, and in some women a re-acquisition of normal menstrual cycle. Furthermore, an abrogation of menopause-related depression, amelioration of hot-flashes and improvement of quality and duration of sleep has been reported.
Myo-inositol is involved in several aspects of human reproduction. Elevated concentrations of myo-inositol in human follicular fluids appear to play a positive function in follicular maturity and provide a marker of good quality oocytes. Nevertheless its positive role in PCOS women is a consequence of a defect in the insulin signalling pathway (inositol-containing phosphoglycan mediators) that seems to be primarily implicated in the pathogenesis of insulin resistance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| myo-inositol | Active comparator | Dietary Supplement: myo-inositol30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months. |
| melatonin | Active comparator | Dietary Supplement: melatonin30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months |
| melatonin plus myo-inositol | Active comparator | Dietary Supplement: melatonin plus myo-inositol30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all pre-menopausal women with irregular cycles and bleedings
Key exclusion criteria (1 listed)
- pre-menopausal women who take hormonal drugs
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 |
|---|---|---|
| melatonin30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months | Dietary supplement | melatonin |
| myo-inositol30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months. | Dietary supplement | myo-inositol |
| melatonin plus myo-inositol30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months | Dietary supplement | melatonin plus myo-inositol |
Primary outcome
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women.
Time frame: 12 months
5 secondary outcomes
Serum assays of thyroid hormones.
Time frame: 12 months
Assays of gonadotropins and estradiol serum levels
Time frame: 12 months
Evaluation of metabolic markers (insulin, glucose, total cholesterol, HDL-cholesterol, triglycerides).
Time frame: 12 months
Variation of blood pressure.
Time frame: 12 months
Variation of mood, hot flashes, quality of sleep.
Time frame: 12 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 2 Mar 2012.
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.
Rosario D'Anna, MD principal investigator
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing melatonin, myo-inositol and melatonin plus myo-inositol in people with Pre-menopausal Irregular Cycles and Bleedings, run by University of Messina 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 1 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 2 Mar 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Normalizing irregular bleeding and anovulatory cycles in pre-menopausal women. (time frame: 12 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 2 Mar 2012.