Hypoactive Sexual Desire Disorder (DSM-IV-TR Defined) Clinical Trial
— PURPLEOfficial title:
A Phase 1-b Non-blinded Study of Safety, Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder
| Verified date | October 2014 |
| Source | S1 Biopharma, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 25 Years to 50 Years |
| Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Robert Taylor Segraves, MD, PhD | Beachwood | Ohio |
| United States | Molly Katz, MD | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| S1 Biopharma, Inc. |
United States,
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Change in Columbia Suicide Severity Rating Scale, Screen Version (6 items) | Brief interview of 3-6 specified questions asking if the patient feels like, wants to, or plans to be dead | 4 weeks after baseline | Yes |
| Primary | 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 | No |
| Secondary | 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. | Four weeks after baseline | No |
| Secondary | 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." | 4 weeks after baseline | Yes |
| Secondary | 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) | 4 Weeks after baseline | No |
| Secondary | Change in blood pressure and pulse | Blood pressure and pulse are taken lying and standing | Four weeks after baseline | Yes |
| Secondary | 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 | 15 weeks (end of last treatment) after screen | Yes |
| Secondary | 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. | Screen (wk 0), end of treatment/new baseline (wks 6, 11, 15) | Yes |