Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined)Phase 1/2PURPLENCT01857596
Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
A Phase 1/2 study testing bupropion, Lorexys low-dose, Lorexys moderate-dose in people with Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) and Sexual Interest/Arousal Disorder (DSM-5 Defined), run by S1 Biopharma, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined), Sexual Interest/Arousal Disorder (DSM-5 Defined)
- What is being tested?
- bupropion, Lorexys low-dose, Lorexys moderate-dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Robert Taylor Segraves, MD, PhD
Beachwood, Ohio, 44122
Molly Katz, MD
Cincinnati, Ohio, 45219
About this study
Official title: A Phase 1-b Non-blinded Study of Safety, Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder
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.
Read the 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.
- Conditions
- Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined), Sexual Interest/Arousal Disorder (DSM-5 Defined)
- Being tested
- bupropion, Lorexys low-dose, Lorexys moderate-dose
- Keywords
- Female Sexual Dysfunction, Hypoactive Sexual Desire Disorder, Sexual Interest/Arousal Disorder, Lorexys, Premenopausal female health
- Medical subject headings
- Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion, Lorexys low-dose, Lorexys moderate-doseDrug
Also called Lorexys is bupropion plus trazodone, Lorexys lower-dose is 225 mg per day., Lorexys moderate-dose is 450 mg per day.
Lorexys is a proprietary fixed-dose combination of two agents
| Study group | Role | What they receive |
|---|---|---|
| Bupropion -> Lorexys LO -> Lorexys HI | Experimental | Crossover with all on positive comparator,lower-dose Lorexys,higher-dose Lorexys Receives: Drug: bupropion, Lorexys low-dose, Lorexys moderate-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks after baseline
Secondary outcomes (6)
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.
Measured: Four weeks after baseline
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."
Measured: 4 weeks after baseline
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)
Measured: 4 Weeks after baseline
Change in blood pressure and pulse
Blood pressure and pulse are taken lying and standing
Measured: Four weeks after baseline
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
Measured: 15 weeks (end of last treatment) after screen
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.
Measured: Screen (wk 0), end of treatment/new baseline (wks 6, 11, 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- S1 Biopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert T Segraves, MD, PhD, Principal investigator, Levine, Risen & Associates, Inc.Molly Katz, MD, Principal investigator, Katz and Kade, Inc.Robert E Pyke, MD, PhD, Study director, Chief Medical Officer, S1 Biopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857596
- Sponsor's protocol ID
- S1P-104-1000
- Acronym
- PURPLE
- Status last verified
- Oct 2014
- First submitted
- 10 May 2013
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21272265
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1-b Non-blinded Study of Safety, Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder
- ClinicalTrials.gov ID
- NCT01857596
- Acronym / sponsor ID
- PURPLE / S1P-104-1000
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- S1 Biopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bupropion -> Lorexys LO -> Lorexys HI | Experimental | Drug: bupropion, Lorexys low-dose, Lorexys moderate-doseCrossover with all on positive comparator,lower-dose Lorexys,higher-dose Lorexys |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion, Lorexys low-dose, Lorexys moderate-doseAlso: Lorexys is bupropion plus trazodone, Lorexys lower-dose is 225 mg per day., Lorexys moderate-dose is 450 mg per day.Lorexys is a proprietary fixed-dose combination of two agents | Drug | Bupropion -> Lorexys LO -> Lorexys HI |
Primary outcome
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.
6 secondary outcomes
Change in Female Sexual Distress Scale-Revised
Time frame: Four weeks after baseline
Change in Side Effects Checklist - 24 item
Time frame: 4 weeks after baseline
Patient's Global Impression of Change
Time frame: 4 Weeks after baseline
Change in blood pressure and pulse
Time frame: Four weeks after baseline
Change in 12-lead electrocardiogram
Time frame: 15 weeks (end of last treatment) after screen
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Background: PubMed 21272265Moll 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert T Segraves, MD, PhD principal investigator
Levine, Risen & Associates, Inc.
Molly Katz, MD principal investigator
Katz and Kade, Inc.
Robert E Pyke, MD, PhD study director
Chief Medical Officer, S1 Biopharma, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bupropion, Lorexys low-dose, Lorexys moderate-dose in people with Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) and Sexual Interest/Arousal Disorder (DSM-5 Defined), run by S1 Biopharma, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Desire domain of the Female Sexual Function Index (time frame: Four weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01857596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2014.