Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating E… (NCT01857596) | Clinical Trial Compass
CompletedPhase 1/2
Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
United States30 participantsStarted 2013-04
Plain-language 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.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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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.
Exclusion criteria
✕. Masturbates more than once a month.
✕. Sexual aversion or sexual pain disorder
What they're measuring
1
Change in Desire domain of the Female Sexual Function Index
. 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