Palatin Technologies, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential, has launched a clinical trial web site (https://www.reconnectstudy.com) in support of its phase III reconnect study with bremelanotide for the treatment of female sexual dysfunction (FSD).
"We are pleased to launch reconnectstudy.com, a web site where women suffering from FSD can go to learn more about their symptoms and a potential new treatment option," said Carl Spana, president and CEO of Palatin. "There are no approved treatments for female sexual dysfunction, which affects more than 40% of women in the U.S."
The web site provides a wealth of information for women, including FAQs on study design, qualification, participation and how to start the enrollment process. It explains that decreased sexual desire is a real medical condition, and provides several personal experiences of women who currently suffer from FSD. It raises awareness of female sexual health and provides information for women interested in participating in a clinical research study designed to evaluate the safety and effectiveness of bremelanotide, a take "as needed" investigational medication for premenopausal women with decreased sexual desire.
Palatin initiated Protocols 301 and 302 of its phase III clinical trial reconnect study in the U.S. and Canada for the treatment of FSD in December 2014 and January 2015. Each pivotal trial of the reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The clinical trials are designed to randomize approximately 1100 women (~550 each trial) to evaluate efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) as an on-demand, as-needed treatment.