Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
Condition: Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined); Sexual Interest/Arousal Disorder (DSM-5 Defined)
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): bupropion, Lorexys low-dose, Lorexys moderate-dose
Intervention type(s): Drug
Intervention description(s): Lorexys is a proprietary fixed-dose combination of two agents
Other intervention name(s): Lorexys is bupropion plus trazodone; Lorexys lower-dose is 225 mg per day.; Lorexys moderate-dose is 450 mg per day.
Intervention MeSH terms: Trazodone; Bupropion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Female Sexual Dysfunction; Hypoactive Sexual Desire Disorder; Sexual Interest/Arousal Disorder; Lorexys; Premenopausal female health