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Three plastic jars of vitamin supplements (two for fertility support and one for womb rebalance) along with a dish of capsules and a paper cutout of the female reproductive system.

The MAP Trial

Myoinositol in Adolescent PCOS- A Trial to Evaluate the Feasibility of a Substantive Trial
Three plastic jars of vitamin supplements (two for fertility support and one for womb rebalance) along with a dish of capsules and a paper cutout of the female reproductive system.

Background

The MAP Trial focuses on adolescents with Polycystic Ovary Syndrome (PCOS), a common endocrine condition affecting approximately 3–11% of teenage girls. The condition often begins around puberty and is characterised by irregular menstrual cycles, hyperandrogenism (such as acne and excess hair), and metabolic disturbances including insulin resistance and obesity. Adolescents with PCOS also face increased long-term risks of type 2 diabetes, cardiovascular disease, infertility, and mental health difficulties including anxiety, depression, and poor body image.

Current treatment approaches are limited. Lifestyle modification is recommended first-line, but pharmacological options such as combined oral contraceptives and metformin are often poorly tolerated or culturally unacceptable to some families. Hormonal treatments may cause weight gain and thromboembolic risks, while metformin commonly causes gastrointestinal side effects. As a result, there is a need for safer, non-hormonal, adolescent-acceptable therapies.

Myoinositol has emerged as a potential alternative treatment. It is a naturally occurring insulin sensitiser that may improve insulin resistance, lower testosterone levels, restore ovulation, and improve PCOS symptoms with minimal side effects. Although evidence in adults is promising, existing studies in adolescents are small, methodologically weak, and inconsistent, meaning robust evidence is lacking.

Reasoning for the study

The rationale for the MAP Trial is based on several factors:

  • Adolescents with PCOS experience substantial physical, emotional, and social burdens during a vulnerable developmental stage.
  • Existing treatments are often poorly tolerated or unacceptable, leading to poor adherence.
  • Preliminary evidence suggests myoinositol may offer clinical benefits with a better safety profile.
  • International PCOS guidelines currently classify inositol as an “experimental therapy” because of insufficient high-quality evidence in adolescents. Previous studies of myoinositol in adolescents have been underpowered, and low quality, highlighting the need for a well-designed randomised controlled trial (RCT).
  • Before investing in a large definitive RCT, researchers need to determine whether such a study is feasible in terms of recruitment, adherence, retention, data collection, and acceptability.

Chief Investigator

Dr Pallavi Latthe

Honorary Associate Professor

Department of Metabolism and Systems Science

Visit Pallavi's PURE profile

Aims of the study

The overall aim of the MAP Trial is to determine whether a large-scale RCT evaluating myoinositol for adolescents with PCOS can be successfully conducted.

Primary aim

To assess the feasibility of conducting a definitive RCT comparing myoinositol with placebo for improving quality of life in adolescents with PCOS.

Primary objectives

The study aims to:

  • Determine the proportion of eligible patients who are screened and recruited.
  • Assess randomisation rates.
  • Measure adherence to treatment.
  • Evaluate completion rates of outcome measures at 6 months.

Secondary objectives

The trial also aims to:

  • Assess the robustness and practicality of data collection methods.
  • Evaluate acceptability of the intervention and outcome measures.
  • Generate estimates needed for future sample size calculations.
  • Identify the level of support required for successful recruitment across NHS sites.
  • Explore adolescents’ and parents’ understanding of PCOS and expectations of treatment.
  • Identify barriers and facilitators to recruitment, adherence, monitoring, and retention.
  • Collect preliminary information on the potential effects of myoinositol on symptoms and quality of life.

We are also adding an optional qualitative study to explore participant and parent experiences, treatment acceptability, and reasons for declining participation, helping refine the design of a future definitive trial.

Study design

Population

Adolescents aged 12–19 years with confirmed PCOS.

Sample size

80 participants (40 per arm).

Sites

Multiple NHS centres including Birmingham, Liverpool, Norwich, and Bristol.

Randomisation

1:1 allocation to:

  • Myoinositol + lifestyle advice
  • Placebo + lifestyle advice

Blinding

Participants, clinicians, and outcome assessors are blinded to treatment allocation.

Intervention duration

6 months.

Participant schedule

Baseline (face-to-face)

Clinical history, height, weight etc, blood tests, menstrual history, The Adolescents’ Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (APQ-20)

3 months (remote)

Adherence review, menstrual diary, The Adolescents’ Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (APQ-20), and Quality of life changes questionnaire

6 months (face-to-face)

Height, weight etc, The Adolescents’ Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (APQ-20), and Quality of life changes questionnaire), menstrual review, adherence and acceptability assessment.

Qualitative component (optional)

Semi-structured interviews to explore treatment acceptability, recruitment barriers, adherence, and participant experiences:

  • 16 participating adolescents
  • 8 parents of participants
  • 8 parents of adolescents who declined participation

Inclusion criteria

Participants must meet all of the following criteria:

  1. Aged 12–19 years
  2. Confirmed Diagnosis of Adolescent PCOS requiring both:
  • Irregular menstrual cycles, defined according to time since menarche:
    • 1–3 years post menarche: cycle length <21 days or >45 days
    • >3 years post menarche: cycle length <21 days or >35 days, or fewer than 8 cycles/year
    • ≥1 year post menarche: any cycle >90 days
    • Primary amenorrhoea by age 15 years or >3 years after thelarche

AND

  • Hyperandrogenism - Clinical or biochemical evidence such as:
    • Significant hirsutism (excess body hair)
    • Severe acne
    • Elevated androgen levels

Exclusion Criteria

Participants will be excluded if any of the following apply:

  • Current medical treatment for PCOS
  • Hormonal therapy within the previous 3 months
  • Myoinositol use within the previous 3 months
  • Other causes of hyperandrogenism including:
    • Non-classical congenital adrenal hyperplasia
    • Androgen-secreting tumour
    • Thyroid dysfunction
    • Hyperprolactinaemia
    • Cushing’s syndrome
    • Inability to provide consent
  • Inability to swallow tablets
  • Known allergy to myoinositol or tablet ingredients
  • Unable to consent independently (for participants ≥16 years)
  • Unable to read or write English

Contact

For further information, please contact mapstudy@contacts.bham.ac.uk.