Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladapti… (NCT01743235) | Clinical Trial Compass
CompletedPhase 2
Lybridos in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder Due to Maladaptive Activation of Sexual Inhibitory Systems
United States207 participantsStarted 2012-07
Plain-language summary
A double-blind, randomized, placebo-controlled, dose-finding study to investigate the safety and efficacy of Lybridos in the domestic setting in healthy female subjects with hypoactive sexual desire disorder and maladaptive activity of sexual inhibitory mechanisms.
In the present study, the efficacy of Lybridos will be evaluated in the domestic setting in healthy female subjects with HSDD and maladaptive activity of sexual inhibitory mechanism(s). Sexual satisfaction and other aspects of sexual functioning will be measured within 24 hours after each sexual activity. The following hypotheses will be tested:
Lybridos, as compared to placebo, will significantly increase the number of satisfying sexual events.
The number of satisfying sexual events will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.
Lybridos, as compared to placebo, will significantly increase sexual desire/arousal.
Sexual desire/arousal will not differ significantly between subjects treated with placebo and subjects treated with 0.5 mg testosterone alone and/or 10 mg buspirone alone.
Lybridos, as compared to testosterone alone and buspirone alone, will significantly increase the number of satisfying sexual events and sexual desire/arousal.
Who can participate
Age range21 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. Provision of written informed consent
✓. Females between 21 and 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder \[FSAD\] and/or female orgasmic disorder \[FOD; only as secondary diagnosis\] is allowed). The diagnosis of HSDD will be established by a trained health care professional.
✓. Maladaptive activity of sexual inhibitory mechanism(s) (see appendix 5 for definition)
✓. Be involved in a stable relationship and have a partner who will be accessible for the majority of the study duration
✓. Healthy with normal medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
Exclusion criteria
✕. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
✕. Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. For subjects ≥ 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg
✕. Use of any contraceptive containing antiandrogens (e.g. Cyproteron acetate) or(anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
✕. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 μg/day of estrogen
✕. Positive test result for Chlamydia or gonorrhea
✕. Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women of child bearing potential prior to the administration of study medications.)
✕. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form