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

Primary Purpose

Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined), Sexual Interest/Arousal Disorder (DSM-5 Defined)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bupropion, Lorexys low-dose, Lorexys moderate-dose
Sponsored by
S1 Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) focused on measuring Female Sexual Dysfunction, Hypoactive Sexual Desire Disorder, Sexual Interest/Arousal Disorder, Lorexys, Premenopausal female health

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Robert Taylor Segraves, MD, PhD
  • Molly Katz, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bupropion -> Lorexys LO -> Lorexys HI

Arm Description

Crossover with all on positive comparator,lower-dose Lorexys,higher-dose Lorexys

Outcomes

Primary Outcome Measures

Change in Desire domain of the Female Sexual Function Index
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
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
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
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
Blood pressure and pulse are taken lying and standing
Change in 12-lead electrocardiogram
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
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.

Full Information

First Posted
May 10, 2013
Last Updated
October 26, 2014
Sponsor
S1 Biopharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01857596
Brief Title
Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
Acronym
PURPLE
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 Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S1 Biopharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined), Sexual Interest/Arousal Disorder (DSM-5 Defined)
Keywords
Female Sexual Dysfunction, Hypoactive Sexual Desire Disorder, Sexual Interest/Arousal Disorder, Lorexys, Premenopausal female health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupropion -> Lorexys LO -> Lorexys HI
Arm Type
Experimental
Arm Description
Crossover with all on positive comparator,lower-dose Lorexys,higher-dose Lorexys
Intervention Type
Drug
Intervention Name(s)
bupropion, Lorexys low-dose, Lorexys moderate-dose
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 Description
Lorexys is a proprietary fixed-dose combination of two agents
Primary Outcome Measure Information:
Title
Change in Desire domain of the Female Sexual Function Index
Description
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.
Time Frame
Four weeks after baseline
Secondary Outcome Measure Information:
Title
Change in Female Sexual Distress Scale-Revised
Description
The subject self-rates 13 negative feelings, such as frustration, bother, and unhappiness, that may have occurred because of her sexual problems.
Time Frame
Four weeks after baseline
Title
Change in Side Effects Checklist - 24 item
Description
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."
Time Frame
4 weeks after baseline
Title
Patient's Global Impression of Change
Description
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)
Time Frame
4 Weeks after baseline
Title
Change in blood pressure and pulse
Description
Blood pressure and pulse are taken lying and standing
Time Frame
Four weeks after baseline
Title
Change in 12-lead electrocardiogram
Description
An electrocardiogram is used to measure the regularity of the heartbeat and how well electrical impulses are transmitted through the heart
Time Frame
15 weeks (end of last treatment) after screen
Title
Change in routine lab studies including pregnancy tests and screen for illicit drugs
Description
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.
Time Frame
Screen (wk 0), end of treatment/new baseline (wks 6, 11, 15)
Other Pre-specified Outcome Measures:
Title
Change in Columbia Suicide Severity Rating Scale, Screen Version (6 items)
Description
Brief interview of 3-6 specified questions asking if the patient feels like, wants to, or plans to be dead
Time Frame
4 weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. In a stable, monogamous, communicative, reasonably amicable relationship for at least one year Meets DSM-IV-TR criteria for Generalized Acquired Hypoactive Sexual Desire Disorder and HSDD is her main sexual disorder Over the prior month, didn't respond to sexual initiations by partner At screen and baseline, low or no and infrequent or rare desire for sex At screen, has clinically relevant sexual distress as per FSDS-R score 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. 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. Gives informed consent for and is willing to undergo all of the scheduled evaluations Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations 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: Masturbates more than once a month. Sexual aversion or sexual pain disorder 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). BMI (a standard ratio of weight to height) over 35.0 (obese) Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs Takes any sex hormone other than an approved hormonal contraceptive 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert T Segraves, MD, PhD
Organizational Affiliation
Levine, Risen & Associates, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Molly Katz, MD
Organizational Affiliation
Katz and Kade, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert E Pyke, MD, PhD
Organizational Affiliation
Chief Medical Officer, S1 Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Robert Taylor Segraves, MD, PhD
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Molly Katz, MD
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21272265
Citation
Moll JL, Brown CS. The use of monoamine pharmacological agents in the treatment of sexual dysfunction: evidence in the literature. J Sex Med. 2011 Apr;8(4):956-70. doi: 10.1111/j.1743-6109.2010.02190.x. Epub 2011 Jan 27.
Results Reference
background

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

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