Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) Clinical Trial
Official title:
A Phase 1-b Non-blinded Study of Safety, Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder
The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree.
Women are diagnosed with Hypoactive sexual desire disorder (HSDD) if they experience chronic
loss of desire for sex together with significant distress or interpersonal difficulties due
to this lack of desire. HSDD can have a serious effect on emotional well-being and
interpersonal relationships.
There are no U.S. Food and Drug Administration-approved treatments for HSDD. Off-label
treatments include testosterone, which is not always effective and can be accompanied by
side effects such as excess hair growth, acne, and decreases in high-density lipoprotein
(HDL) cholesterol levels.
Research in laboratory animals and clinical observations in humans suggest that re-balancing
chemical messengers in the brain may stimulate sexual desire. S1 Biopharma's Lorexys® is a
novel use fixed-dose combination (FDC) in an oral pill. Lorexys® combines two agents
intended to restore balance to the brain's centers that control sexual function. Such
effects are hoped to help women with HSDD.
The compound is Phase 2-ready without prior trials (Phase I safety studies) because the two
agents have often been used together; individually, they are FDA-approved for treating other
disorders (depression, for example), and in a large US survey, the two were taken together
in about 23% of patients who were prescribed one of the two agents.
This research study requires subjects to take three different study medications for four
weeks each, with at least a one-week "wash-out" period after each, and to report on rating
scales how they feel. The medication is open-label (the subjects can see which medication
they are receiving). That should not interfere with the evaluations or cause a big "placebo
effect" because only a low proportion of women with HSDD have responded to a placebo in
prior research studies of other compounds when using the same measures of efficacy.
Participation lasts 16 weeks, with 8 clinic visits. A weekly, but no daily, self-rating is
required between visits.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment