Lorexys Study S1P-104-1000, a Phase 2a Clinical Trial
The study’s primary objective was to evaluate Lorexys’ safety, tolerability and pro-sexual efficacy as compared to bupropion, one of its constituent drugs. Other objectives include exploration of the onset and duration of action of Lorexys as well as determination of the optimal dose to be used in future trials.
The clinical trial had an adaptive, three-way crossover, open-label design. It enrolled 30 premenopausal women who met the DSM-IV-TR criteria for HSDD, and it was the first trial to also assess such patients for the newly defined DSM-5 Sexual Interest and Arousal Disorder. Each subject received a daily dose of bupropion as an active control for four weeks followed by a week-long washout period, then daily administration of a low dose of Lorexys for four weeks followed by the washout, and, finally, a moderate dose of Lorexys followed by another washout.
Patients self-evaluated weekly with questionnaires and were assessed during eight clinic visits. Outcome measures for efficacy included validated self-rated scales of Sexual Function and Sexual Distress and global change. Outcome measures for safety included comprehensive evaluations of symptoms and vital signs, plus standard laboratory studies and electrocardiograms. The study was conducted at two clinical sites in the U.S.