LPRI-424 in the treatment of polycystic ovary syndrome (PCOS)

• Research type

  Research Study

• Full title

  A multicentre, phase III, double-blind, randomised clinical trial to assess the efficacy and safety of LPRI-424 (dienogest 2.00 mg / ethinyl estradiol 0.02 mg) in the treatment of polycystic ovary syndrome (PCOS) versus placebo during 9 cycles

• IRAS ID

  1006162

• Contact name

  Enrico Colli

• Contact email

  Enrico.Colli@exeltis.com

• Sponsor organisation

  Chemo Research S. L.

• Eudract number

  2021-002178-17

• ISRCTN Number

  ISRCTN76318215

• Research summary

  The test medicine (LPRI-424) is being given to women with polycystic ovary syndrome to see if there is a change in hair growth when given for 9 months. This is being tested against a placebo and the hair growth is being measured by a tool called the Adapted Modified Ferriman-Gallwey (mFG) score. This score is used by Doctors to see how much hair growth there is for those suffering with poly-cystic ovary syndrome.

• REC name

  Wales REC 5

• REC reference

  22/WA/0230

• Date of REC Opinion

  13 Sep 2022

• REC opinion

  Further Information Favourable Opinion