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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S1 Biopharma, Inc.
• Treatments: Bupropion; Trazodone

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.