Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder (NCT02101203) | Clinical Trial Compass
CompletedPhase 2
Lybridos in Pre-and Postmenopausal Women With Hypoactive Sexual Desire Disorder
United States80 participantsStarted 2013-07
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.
This is a 2-arm placebo and Lybridos (0.5 mg testosterone + buspirone 10 mg) extension to study EB90 (Clinical Study Protocol EB90a, version 3.0, 07 June 2013).
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.
Objectives:
To investigate the efficacy of Lybridos as compared to placebo in increasing the number of satisfactory sexual episodes in healthy female subjects with hypoactive sexual desire disorder (HSDD) and maladaptive activity of sexual inhibitory mechanisms
* To identify the optimal dose of Lybridos to take into phase 3 clinical development
* To confirm that Lybridos has superior efficacy as compared to testosterone alone and to buspirone alone
* To evaluate the effect of Lybridos as measured by scales of sexual satisfaction and/or sexual desire/arousal
* To evaluate the safety profile of Lybridos
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 4 for definition)
✓. Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration
✓. Healthy according to normal results of 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
What they're measuring
1
The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).
✕. Use of any contraceptive containing anti-androgens (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