Date: 2014-11-18
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Obseva (Switzerland)
Product: OBE001
Action
mechanism: OBE001 is a new generation of oxytocin antagonist. The objective is to inhibit uterine contractions, by administering OBE001, at the time of embryo transfer, to enhance embryo implantation during ART and increase ART Take Home Baby rate.
Disease: enhancement of embryo transplantation during assisted reproductive technologies
Therapeutic area: Women health - Reproductive medicine
Country: Belgium, Czech Republic, Denmark, Poland, Spain, UK
Trial
details: The study is a prospective, dose-finding randomised, parallel group, double-blind, placebo-controlled study. It is planned to recruit 240 patients at 30 specialist IVF centres across 6 European countries including Belgium, Czech Republic, Denmark, Poland, Spain and UK.
Latest
news: * On November 18, 2014, ObsEva, a Swiss biopharmaceutical company dedicated to the development and commercialization of innovative drugs for women\'s reproductive medicine, announced the initiation of a Phase 3-enabling, Phase 2 study of OBE001, a novel orally active oxytocin receptor antagonist. The IMPLANT study is designed to assess the safety and efficacy of a range of doses of OBE001 compared to placebo in women undergoing embryo transfer after IVF/ICSI. The primary objective of this study is to assess the increase in clinical pregnancy rate. \"The study will recruit women who are at risk of embryo implantation failure due to the presence of uterine contractions at the time of embryo transfer\" added Andrew Humberstone, Head of Clinical Operations of ObsEva. \"They will be administered a single, oral dose of OBE001 or placebo before embryo transfer\".
The specialist IVF centre at Brussels Hospital University (UZB) in Belgium has been the first site to be initiated on November 17, 2014. Professor Herman Tournaye is the principal investigator for the IMPLANT study at that site.
