The effect of myoinositol (MI) or metformin treatment on symptoms of polycystisk ovary syndrome (PCOS), including metabolism, menstrual pattern, quality of life and mental health.

The effect of myoinositol (MI) or metformin treatment on symptoms of polycystisk ovary syndrome (PCOS), including metabolism, menstrual pattern, quality of life and mental health. - Myoinositol or metformin in PCOS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004506-34-DK

Enrollment

Registered

2016-11-21

Start date

2017-01-26

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome (PCOS) MedDRA version: 19.1 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872

Interventions

Trade Name: Metformin Product Name: metformin Pharmaceutical Form: Tablet INN or Proposed INN: METFORMIN HYDROCHLORIDE CAS Number: 1115-70-40 Concentration unit: mg/g milligram(s)/gram Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-50 years Women with PCOS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Postmenopausal Dysregulated type 2 diabetes Type 1 diabetes Use of systemic hormonal contraceptives within 3 months Use og metformin within 1 month

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of the dietary supplement myoinositol compared to the drug metformin in women with polycystic ovarian syndrome (PCOS). PCOS is characterized by irregular menstruations, high blood levels of male hormones, and increased male hair growth. Myoinositol and metformin decrease insulin resistance. The effect of myoinositol on symptoms of PCOS is not fully investigated and we investigate the effect compared to standard treatment with metformin. In the trial we investigate the effect on anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.;Secondary Objective: Not applicable;Primary end point(s): Insulin sensitivity estimated by homeostatic model assessment of insulin resistance (HOMA-IR);Timepoint(s) of evaluation of this end point: Baseline and after 6 months' treatment	—

Measure

Time frame

Main Objective: To investigate the effect of the dietary supplement myoinositol compared to the drug metformin in women with polycystic ovarian syndrome (PCOS). PCOS is characterized by irregular menstruations, high blood levels of male hormones, and increased male hair growth. Myoinositol and metformin decrease insulin resistance. The effect of myoinositol on symptoms of PCOS is not fully investigated and we investigate the effect compared to standard treatment with metformin. In the trial we investigate the effect on anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.;Secondary Objective: Not applicable;Primary end point(s): Insulin sensitivity estimated by homeostatic model assessment of insulin resistance (HOMA-IR);Timepoint(s) of evaluation of this end point: Baseline and after 6 months' treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in anthropometric measures, glucose metabolism, blood lipids, mental health, quality of life, sex hormones, menstrual pattern and side effects.;Timepoint(s) of evaluation of this end point: Baseline and after 6 months' treatment	—

Countries

Denmark

Contacts

Public ContactPernille Ravn

Odense Universitetshospital

pernille.ravn@rsyd.dk004528435625

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026