Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety (PURPLE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by S1 Biopharma, Inc.
Sponsor:
Information provided by (Responsible Party):
S1 Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01857596
First received: May 10, 2013
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined)
Sexual Interest/Arousal Disorder (DSM-5 Defined)
Drug: Active Control, Lorexys Lower-dose, Lorexys higher-dose
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by S1 Biopharma, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 30
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)
Arms Assigned Interventions
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.
Other Names:
  • Active control is bupropion (see "Citations" below about its effects).
  • Lorexys lower-dose for the first 10-15 subjects is 225 mg per day.
  • Lorexys higher-dose for the first 10-15 subjects is 450 mg per day.
  • The dose strength of the lower-dose and higher-dose may be altered
  • for the rest of the 30 patients to no more than 225 or as much as
  • 700 mg per day depending on how well Lorexys is tolerated in the
  • first 10-15 subjects.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 25 to 50 and still having regular menstrual periods. Women with intact ovaries are classified as premenopausal for this study, even if they have had a hysterectomy. Women who have had both ovaries removed, even if under age 50 and with an intact uterus, are not acceptable for this study.
  2. In a stable, monogamous, communicative, reasonably amicable relationship for at least one year
  3. Meets DSM-IV-TR criteria for Generalized Acquired Hypoactive Sexual Desire Disorder and HSDD is her main sexual disorder
  4. Over the prior month, didn't respond to sexual initiations by partner
  5. At screen and baseline, low or no and infrequent or rare desire for sex
  6. At screen, has clinically relevant sexual distress as per FSDS-R score
  7. Otherwise healthy physically and mentally. Minor chronic conditions not affecting sexual function are allowed. Side effects from any continuing concomitant medications must be mild and stable or nil.
  8. Not pregnant or lactating for six months; using medically reliable contraception, i.e., diaphragm or (male or female) condom and spermicide, IUD, tubal sterilization, hormonal contraception (oral, vaginal, or implant), or (if the investigator finds the patient credibly monogamous) vasectomy of male partner.
  9. Gives informed consent for and is willing to undergo all of the scheduled evaluations
  10. Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations
  11. Her sexual partner is in a monogamous relationship with her, is sexually unimpaired (erectile dysfunction allowed only if adequately treated), and is available to her at least half of the time (in days per week).

Exclusion Criteria:

  1. Masturbates more than once a month.
  2. Sexual aversion or sexual pain disorder
  3. Chronic conditions that may reasonably be expected to be unstable or to affect sexual function (e.g., gastrointestinal bleeding, diabetes, frequent asthma, Major Depressive or anxiety disorder, history within the prior 6 months of suicidality or drug abuse; history of breast, cervical, uterine, ovarian or other systemic cancer).
  4. BMI (a standard ratio of weight to height) over 35.0 (obese)
  5. Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs
  6. Takes any sex hormone other than an approved hormonal contraceptive
  7. Takes an antiepileptic/mood stabilizer, antipsychotic, antidepressant, anti-anxiety, or hypnotic drug or has a history of allergic reaction to such drugs

9. Drinks more than 7 alcoholic drinks per week (12-oz beer, 4-oz wine, 1 ½ oz liquor etc) 10. Drinks more than 6 cups of coffee or tea per day 11. History of seizures 12. Long QT syndrome (QTc <=480 msec), other significant cardiovascular disease 13. moderate or severe dysfunction of the liver (any LFT >=3x ULN) or renal dysfunction (BUN > 30 or Cr >2.0) 14. Uses sedating antihistamines or prescription sedatives 15. History of blood clots or abnormal bleeding tendencies, including daily use of medications adversely affecting coagulation, e.g., NSAIDs, systemic corticosteroids, or >81 mg aspirin daily.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01857596

Locations
United States, Ohio
Robert Taylor Segraves, MD, PhD Recruiting
Beachwood, Ohio, United States, 44122
Contact: Denise Sheridan    216-831-2900 ext 23    dlshrdn@aol.com   
Molly Katz, MD Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Laura Providenti    513-723-2254    kandklaurap@gmail.com   
Sponsors and Collaborators
S1 Biopharma, Inc.
Investigators
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.
  More Information

Publications:
Responsible Party: S1 Biopharma, Inc.
ClinicalTrials.gov Identifier: NCT01857596     History of Changes
Other Study ID Numbers: S1P-104-1000
Study First Received: May 10, 2013
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by S1 Biopharma, Inc.:
Female Sexual Dysfunction
Hypoactive Sexual Desire Disorder
Sexual Interest/Arousal Disorder
Lorexys
Premenopausal female health

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Disease
Hypokinesia
Dyskinesias
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014