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OCT, Eastern Europe’s leading CRO, partners with UK-based Futura Medical; completes clinical trial enrolment for MED2002, a topical gel developed to treat erectile dysfunction.
SAINT PETERSBURG, Russia — August 16, 2019. OCT Clinical Trials, the leading CRO in Russia and Eastern Europe since 2005, announced it has successfully completed enrollment of 690 patients for a phase III efficacy study of a drug for male erectile dysfunction. This is a dose ranging, multicenter, randomized, double-blind, placebo-controlled, home use, parallel group clinical trial of MED2002, which is a topical gel developed by UK-based pharmaceutical company Futura Medical.
The study’s participants are males aged 18 to 70 undergoing a 12-week treatment with three active variations of dosage. The effects of long-term treatment (up to 12 months) will be evaluated as well in an open label extension phase (OLE). Recruitment started in October 2018 and the last patient was screened in June 2019. Over one thousand patients were randomized into the study within nine months with a screen failure rate of only nine percent, which was in line with initial projections and sponsor's expectations.
The phase III study of MED2002 is now ongoing in 9 European countries. OCT is overseeing all major activities in four of them, with 20 sites in Russia, five in Bulgaria, eight in Ukraine and three in Latvia. Sixty-nine percent of all patients were recruited by OCT in four countries, while another CRO enrolled 315 patients in six other countries.
Successful enrollment for this study was due to OCT’s in-depth feasibility analysis and thorough study planning, as well as high professionalism of experienced CRAs who demonstrated excellent ability to work collaboratively with sites, swiftly resolving any issues that arose during the enrollment. In addition, OCT’s local expertise in Russia helped clarify several key issues for the sponsor regarding logistical and regulatory matters.
Headline data for the study is planned to be made available by the end of 2019.
About Futura Medical
Futura Medical is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk. Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. Learn more at www.FuturaMedical.com.
August 16, 2019
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