Myoinositol in adolescent polycystic ovary syndrome

ISRCTN	ISRCTN56505721
DOI	https://doi.org/10.1186/ISRCTN56505721
Integrated Research Application System (IRAS)	362931
Central Portfolio Management System (CPMS)	63107
Sponsor	University of Birmingham
Funder	Action Medical Research

Submission date: 15/05/2026
Registration date: 19/05/2026
Last edited: 20/05/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Polycystic Ovary Syndrome (PCOS) is a common hormonal condition that affects many teenage girls. It can cause irregular periods, acne, excess hair growth, and emotional distress. PCOS also increases the risk of long-term health problems like diabetes and heart disease. Current treatments often involve hormonal medications, which some young people and families are reluctant to use due to side effects or cultural concerns. This study, called the MAP Trial, will test whether a natural food supplement called myoinositol could be a helpful alternative. Myoinositol has shown promise in adults with PCOS, but it hasn’t been properly studied in teenagers. The MAP Trial is a feasibility study, which means it won’t test how well the supplement works just yet – it will check whether a larger trial is possible.

Who can participate?
Girls aged 12–19 years with confirmed PCOS from six NHS hospitals in England (Birmingham, Liverpool, Norwich, and Bristol)

What does the study involve?
Participants will be randomly assigned to take either myoinositol or a placebo (inactive tablet) for 6 months, along with lifestyle advice. We will monitor how many girls agree to take part, how well they stick to the treatment, and how easy it is to collect the necessary data. The study will collect information about symptoms, quality of life, and routine blood tests over three routine appointments. We will also interview some participants and their parents to understand their experiences and views. This will help us improve the design of a future trial.

What are the possible benefits and risks of participating?
Participants may feel better with the treatment. Even if it doesn’t help you directly, what we learn might help other teenagers with PCOS in the future. The main effort will be completing the questionnaires, which take about 10–15 minutes.

Where is the study run from?
University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
July 2026 to October 2027

Who is funding the study?
Action Medical Research for Children (UK)

Who is the main contact?
mapstudy@contacts.bham.ac.uk

Contact information

Dr Pallavi Latthe
Scientific, Principal investigator

Birmingham Women's Hospital, Mindelsohn Way, Edgbaston
Birmingham
B15 2TG
United Kingdom

ORCID ID	0000-0003-0529-0409
Phone	+44 (0)121 472 1377
Email	platthe@nhs.net

Mrs Rachel Iles
Public

Institute Translational Medicine, Heritage Building, Queen Elizabeth Hospital, Edgbaston
Birmingham
B15 2TH
United Kingdom

Phone	+44 (0)1213715339
Email	r.iles@bham.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Device feasibility, Health services research, Supportive care
Scientific title	Myoinositol in adolescent polycystic ovary syndrome – a trial to evaluate the feasibility of a substantive trial
Study acronym	MAP
Study objectives
Ethics approval(s)	Approved 05/05/2026, North West Greater Manchester West Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8057; gmwest.rec@hra.nhs.uk), ref: 26/NW/0108
Health condition(s) or problem(s) studied	Polycystic ovary syndrome
Intervention	Myoinositol 2 g BD (twice a day) or placebo for 6 months Participants are randomised by the REDCap database using a 1:1 allocation ratio (myoinositol vs placebo). A minimisation algorithm is used within REDCap to ensure balance in site, age (≥16 and <16 years), and weight (≥ or <95th BMI centile for age). A random element is also included to avoid predictability.
Intervention type	Supplement
Primary outcome measure(s)	Adherence rates measured using participant questionnaires at 3 and 6 months Completion rates of proposed primary outcome measure measured using participant questionnaires at 6 months Acceptability of outcome measures (patient-reported outcome measures [PROMs] identified included excessive body and facial hair, emotional wellbeing, mood and self-esteem, body image, and weight-related concerns) measured using participant questionnaires at baseline, 3 and 6 months Participants' and parental perspectives (disease literacy: their understanding of the condition, its progress and the rationale for treatment; treatment expectations: what they hope to achieve through the intervention [e.g. symptom relief, long term cure]; determinants of study engagement [identifying specific facilitators and barriers to]: recruitment: factors influencing the initial decision to enrol; adherence: challenges or supports in following the treatment regimen; monitoring and data collection; retention: motivations or obstacles to staying in the study until completion) measured using qualitative interviews at 6 months
Key secondary outcome measure(s)	The study will inform whether a larger RCT can be realistically undertaken and identify potential barriers to its successful completion by assessing the following after patient recruitment has ended: 1. Robustness of data collection processes 2. Proportion of eligible patients screened 3. Proportion of eligible patients randomised 4. Data to inform sample size calculation for main trial 5. Support required for successful recruitment
Completion date	29/10/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	12 Years
Upper age limit	19 Years
Sex	Female
Target sample size at registration	80
Key inclusion criteria	1. Age 12-19 years 2. Confirmed diagnosis of adolescent PCOS based on international consensus criteria requiring both: 2.1. Irregular menstrual cycles, defined as: 2.1.1. 1-3 years post menarche: <21 days or >45 days 2.1.2. >3 years post menarche: <21 or >35 days or <8 cycles per year 2.1.3. 1 year post menarche: >90 days for any cycle, or 2.1.4. Primary amenorrhoea by age 15 years or >3 years after thelarche with 2.2. Biochemical or clinical hyperandrogenism such as significant hirsutism or severe acne
Key exclusion criteria	1. Current medical treatment for PCOS 2. Hormonal use within previous 3 months 3. Myoinositol use within previous 3 months 4. Other medical causes of hyperandrogenism such as idiopathic hyperandrogenism, non-classical congenital adrenal hyperplasia, thyroid dysfunction, hyperprolactinaemia, Cushing’s syndrome and androgen-secreting tumour 5. Inability to provide consent, or inability to swallow tablets 6. Known allergy to any of the tablet ingredients 7. Unable to consent for participants aged 16 years and over 8. Cannot read or write English
Date of first enrolment	01/07/2026
Date of final enrolment	30/04/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

Birmingham Childrens Hospital

Steelhouse Lane
Birmingham
B4 6NH
England

Birmingham Womens Hospital

Mindelsohn Way
Birmingham
B15 2TG
England

Liverpool Women's Hospital

Liverpool Womens Hospital
Crown Street
Liverpool
L8 7SS
England

Alder Hay Childrens Hospital

Prescot Rd
Liverpool
L14 5AB
England

St Michaels Hospital

Southwell Street
Bristol
BS2 8EG
England

Norfolk & Norwich University Hospital

Colney Lane
Colney
Norwich
NR4 7UY
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

20/05/2026: Internal review.
15/05/2026: Study's existence confirmed by the North West Greater Manchester West Research Ethics Committee.