Polycystic ovary syndrome Nutritional, Metabolic, Endocrine
Conditions
Interventions
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 wit
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Age
12 Years to 19 Years
Inclusion criteria
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: 45 days 2.1.2. >3 years post menarche: 35 days or 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactRachel Iles
Outcome results
None listed