Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety (PURPLE)
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.
Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined)
Sexual Interest/Arousal Disorder (DSM-5 Defined)
Drug: Active Control, Lorexys Lower-dose, Lorexys higher-dose
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1-b Non-blinded Study of Safety, Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder|
- Change in Desire domain of the Female Sexual Function Index [ Time Frame: Four weeks after baseline ] [ Designated as safety issue: No ]One item asks how often the subject feels sexual desire, and another item asks how much she feels desire. One of five answers must be checked for each item.
- Change in Female Sexual Distress Scale-Revised [ Time Frame: Four weeks after baseline ] [ Designated as safety issue: No ]The subject self-rates 13 negative feelings, such as frustration, bother, and unhappiness, that may have occurred because of her sexual problems.
- Change in Side Effects Checklist - 24 item [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: Yes ]The subject self-rates how much (if any) she has been bothered by each of the 24 symptoms that have been commonly reported with similar drugs, such as headache, sleepy, and anxious, from "not at all" to "extremely."
- Patient's Global Impression of Change [ Time Frame: 4 Weeks after baseline ] [ Designated as safety issue: No ]Subject self-rates how much, if any, her sexual disorder has changed since starting the current study medication (worse, same, or 4 degrees of improvement)
- Change in blood pressure and pulse [ Time Frame: Four weeks after baseline ] [ Designated as safety issue: Yes ]Blood pressure and pulse are taken lying and standing
- Change in 12-lead electrocardiogram [ Time Frame: 15 weeks (end of last treatment) after screen ] [ Designated as safety issue: Yes ]An electrocardiogram is used to measure the regularity of the heartbeat and how well electrical impulses are transmitted through the heart
- Change in routine lab studies including pregnancy tests and screen for illicit drugs [ Time Frame: Screen (wk 0), end of treatment/new baseline (wks 6, 11, 15) ] [ Designated as safety issue: Yes ]About two teaspoons of blood are drawn to measure blood cells and body chemistry, and to see if the patient has become pregnant or has taken unauthorized substances.
- Change in Columbia Suicide Severity Rating Scale, Screen Version (6 items) [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: Yes ]Brief interview of 3-6 specified questions asking if the patient feels like, wants to, or plans to be dead
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Bupropion -> Lorexys LO -> Lorexys HI
Crossover with all on positive comparator,lower-dose Lorexys,higher-dose Lorexys
Drug: Active Control, Lorexys Lower-dose, Lorexys higher-dose
Bupropion is a mild stimulant possibly with modest, not well-proven pro-sexual effects, taken daily at a previously-approved dose for four weeks. Lorexys is a proprietary fixed-dose combination of agents active in the brain.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01857596
|United States, Ohio|
|Robert Taylor Segraves, MD, PhD||Recruiting|
|Beachwood, Ohio, United States, 44122|
|Contact: Denise Sheridan 216-831-2900 ext 23 firstname.lastname@example.org|
|Molly Katz, MD||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Laura Providenti 513-723-2254 email@example.com|
|Principal Investigator:||Robert T Segraves, MD, PhD||Levine, Risen & Associates, Inc.|
|Principal Investigator:||Molly Katz, MD||Katz and Kade, Inc.|
|Study Director:||Robert E Pyke, MD, PhD||Chief Medical Officer, S1 Biopharma, Inc.|