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

NCT01857596 | Completed Phase 1

• 1 other identifier: S1P-104-1000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Four weeks after baseline

Secondary Outcomes (6)

• Change in Female Sexual Distress Scale-Revised

  Four weeks after baseline

• Change in Side Effects Checklist - 24 item

  4 weeks after baseline

• Patient's Global Impression of Change

  4 Weeks after baseline

• Change in blood pressure and pulse

  Four weeks after baseline

• Change in 12-lead electrocardiogram

  15 weeks (end of last treatment) after screen

Other Outcomes (1)

• Change in Columbia Suicide Severity Rating Scale, Screen Version (6 items)

  4 weeks after baseline

Study Arms (1)

Bupropion -> Lorexys LO -> Lorexys HI

EXPERIMENTAL

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

Drug: bupropion, Lorexys low-dose, Lorexys moderate-dose

Interventions

bupropion, Lorexys low-dose, Lorexys moderate-dose DRUG

Lorexys is a proprietary fixed-dose combination of two agents

Also known as: Lorexys is bupropion plus trazodone, Lorexys lower-dose is 225 mg per day., Lorexys moderate-dose is 450 mg per day.

Bupropion -> Lorexys LO -> Lorexys HI

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• \. 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.

Sponsors & Collaborators

• S1 Biopharma, Inc.: lead

Study Sites (2)

Robert Taylor Segraves, MD, PhD

Beachwood, Ohio, 44122, United States

Location

Molly Katz, MD

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• 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.

  PMID: 21272265 BACKGROUND

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological

Interventions

Bupropion; Trazodone

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Robert T Segraves, MD, PhD

  Levine, Risen & Associates, Inc.

  PRINCIPAL INVESTIGATOR

• Molly Katz, MD

  Katz and Kade, Inc.

  PRINCIPAL INVESTIGATOR

• Robert E Pyke, MD, PhD

  Chief Medical Officer, S1 Biopharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 20, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

US (2)