Liraglutide in PCOS

• Research type

  Research Study

• Full title

  Liraglutide in PCOS (LIPOS) Study: Evaluation of the Efficacy of Liraglutide on Menstrual Cyclicity in Women with PCOS - a prospective randomised double-blind placebo-controlled study

• IRAS ID

  109056

• Contact name

  Harpal S Randeva

• Eudract number

  2012-002073-60

• ISRCTN Number

  N/a

• Research summary

  Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, characterized by: (i) irregular or no periods; (ii) increased levels of male sex hormones giving unwanted hair growth and acne; and (iii) cysts around the edges of the ovaries. PCOS is linked to a number of problems such as obesity, increased blood levels of insulin and type 2 diabetes. Drug treatment options include the use of oral contraceptives, metformin (a drug for diabetes), and orlistat (a weight loss drug). Metformin is used for the symptomatic management of polycystic ovary syndrome. Metformin improves how the body uses insulin, may aid weight reduction, helps to normalise menstrual cycles (increasing the rate of spontaneous ovulation) and may reduce unwanted hair growth. A hormone called glucagon like peptide-1 (GLP1) is produced in the gut after eating. GLP1 increases the secretion of insulin and also slows down the passage of food leading to an increased feeling of fullness. Liraglutide is a modified form of GLP1 which has similar effects to the natural hormone. Liraglutide is used for the treatment of patients with type 2 diabetes and is given as a once daily subcutaneous (under the skin) injection. Studies have shown that liraglutide causes weight loss in some patients by reducing the amount of food they eat. Treatment with exenatide (another GLP1 synthetic drug) significantly improves the regularity of periods in PCOS women. The main purpose of this study is to investigate whether adding liraglutide (at a maximum dose of 1.8 mg once daily) to metformin (at a maximum dose of 1000 mg twice daily) for 52 weeks of treatment has a significant benefit in improving the regularity of periods. Also this study will explore the effects of liraglutide on weight loss and on other cardiometabolic parameters in PCOS women.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  12/WM/0247

• Date of REC Opinion

  21 Sep 2012

• REC opinion

  Further Information Favourable Opinion