WHO ICTRP trial

Assess safety and efficacy of vilaprisan in subjects with endometriosis

EUCTR2013-004768-72-FI · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2013-004768-72-FI
Public title Assess safety and efficacy of vilaprisan in subjects with endometriosis
Scientific title A randomized, double-blind, parallel-group, multicenter Phase 2b study to assess the efficacy and safety of two different doses of vilaprisan (BAY 1002670) versus placebo in women with symptomatic endometriosis - Villendo
Primary sponsor Bayer AG
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Portugal;Taiwan;Finland;Spain;Austria;Switzerland;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany;China;Japan;Sweden
Conditions Pre-menopausal women 18 years and older with confirmed endometriosis and moderate to severe endometriosis-associated pelvic pain (EAPP), otherwise in good general health. MedDRA version: 20.0 Level: PT Classification code 10014778 Term…
Interventions Product Name: BAY 1002670 coated tablet 2 mg Product Code: BAY 1002670 Pharmaceutical Form: Coated tablet INN or Proposed INN: vilaprisan CAS Number: 1262108-14-4 Current Sponsor code: BAY 1002670 Other descriptive name: BAY 1002670…
Registration date Apr 27, 2018
Target size 315
Secondary IDs BAY1002670/15792;2013-004768-72-AT
Registry page clinicaltrialsregister.eu

At a glance

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