Myoinositol in adolescent polycystic ovary syndrome – a trial to evaluate the feasibility of a substantive trial
Polycystic ovary syndrome
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.
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
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