ASP1707 in Subjects with Endometriosis Associated Pelvic Pain

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Assess the Efficacy, Safety, and Dose-Response Relationship of ASP1707 in Subjects with Endometriosis Associated Pelvic Pain for 12 Weeks, Followed by a 12-Week Double-blind Extension without Placebo Control, Including a 24-Week Open-Label Leuprorelin Acetate Treatment Group for Bone Mineral Density Assessment

• IRAS ID

  116081

• Contact name

  Edward Morris

• Sponsor organisation

  Astellas Pharma Europe B.V.

• Eudract number

  2012-002791-14

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The main objective for this study is to assess the efficacy and dose-response relationship of ASP1707 in reduction of endometriosis associated pelvic pain. The secondary objectives are to assess the safety, tolerability, PK of ASP1707, dose response relationship of ASP1707 in reduction of E2 (Estradiol), 24-week efficacy of ASP1707 in reduction of endometriosis associated pain and 24-week safety and tolerability of ASP1707.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  13/EE/0023

• Date of REC Opinion

  13 Mar 2013

• REC opinion

  Further Information Favourable Opinion