Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety (PURPLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01857596|
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : October 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) Sexual Interest/Arousal Disorder (DSM-5 Defined)||Drug: bupropion, Lorexys low-dose, Lorexys moderate-dose||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1-b Non-blinded Study of Safety, Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Bupropion -> Lorexys LO -> Lorexys HI
Crossover with all on positive comparator,lower-dose Lorexys,higher-dose Lorexys
Drug: bupropion, Lorexys low-dose, Lorexys moderate-dose
Lorexys is a proprietary fixed-dose combination of two agents
- Change in Desire domain of the Female Sexual Function Index [ Time Frame: Four weeks after baseline ]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 ]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 ]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 ]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 ]Blood pressure and pulse are taken lying and standing
- Change in 12-lead electrocardiogram [ Time Frame: 15 weeks (end of last treatment) after screen ]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) ]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 ]Brief interview of 3-6 specified questions asking if the patient feels like, wants to, or plans to be dead
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857596
|United States, Ohio|
|Robert Taylor Segraves, MD, PhD|
|Beachwood, Ohio, United States, 44122|
|Molly Katz, MD|
|Cincinnati, Ohio, United States, 45219|
|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.|