Female Sexual Dysfunction, specifically Hypoactive Sexual Desire Disorder, with or without Female Sexual Arousal Disorder. MedDRA version: 9.1 Level: LLT Classification code 10020933 Term: Hypoactive sexual desire disorder
Conditions
Interventions
Product Name: Lybridos
Product Code: Lybridos
Pharmaceutical Form: Capsule*
INN or Proposed INN: TESTOSTERONE
CAS Number: 58220
Current Sponsor code: testosterone sublingual
Concentration unit: mg mil
Sponsors
Emotional Brain
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Thirteen (13) premenopausal and postmenopausal women with Hypoactive Sexual Desire Disorder (HSDD), with or without Female Sexual Arousal Disorder (FSAD). Additionally, subjects must meet the following criteria: 1 Subjects must have a heterosexual orientation. 2 Subjects must be between 21 and 70 years of age. 3 Subjects must have experienced low sexual arousal and / or low sexual desire for at least six months prior to study entry according to DSM IV criteria. The diagnosis will be made by an experienced psychologist/sexologist. 4 Subjects must have signed the Informed Consent Form. 5 Inclusion will be following the selection criteria including, but not limited to, a physical examination, gynecological examination, medical history, vital signs, pregnancy test and ECG, and by the scoring on the Stroop task during familiarization trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for inclusion if one of the following criteria applies: 1 Use of oral contraception containing anti-androgens (Like Diane 35 or Minerva); 2 Use of oral contraception containing 50 µg estrogen or more; 3 Pregnancy, or intention to become pregnant during this study (Note: a serum or urine pregnancy test will be performed in all women prior to the administration of study medications); 4 A pelvic inflammatory disease or an untreated vaginal infection at screening; 5 Lactating or subjects who have given birth in the previous 6 months; 6 Previous prolapse and incontinence surgery affecting the vaginal wall; 7 Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns; 8 History of endocrinological treatment or current endocrinological treatment (with the exception of the use oral contraceptives and of fertility-promoting treatment); 9 History of moderate or severe neurological complaints or current moderate or severe neurological complaints and/or treatment for current moderate or severe neurological complaints; 10 History of moderate or severe psychiatric complaints or current moderate or severe psychiatric complaints and/or treatment for current moderate or severe psychiatric complaints; 11 History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months; 12 Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG; 13 Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg. For subjects with age > 60 years and without diabetic mellitus, familiar hypercholesterolemia or cardiovascular disease: Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 90 mmHg (According to the CBO-guideline hypertension (CBO.2000a)). Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg 14 Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol 15 Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir 16 Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine 17 Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment; 18 Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression) 19 Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, SSRIs, TCAs, Tramadol; 20 A substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study; mild or moderately alcohol drinking behavior is allowed, only 12 hours before the experimental days is alcohol drinking not allowed. Three weeks before the start of the experimental day is the taking of any recreational drug not allowed. Smoking is allowed. 21 Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices; 22 Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires; 23 Any other clinically significant abnormality or condition which in the op
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate efficacy of Lybridos on physiological and subjective indices of sexual arousal in healthy female subjects with Female Sexual Dysfunction. ;Secondary Objective: Secondary objectives: - To investigate Lybridos’ influence on attentional bias for erotic stimuli. - To evaluate the safety of Lybridos. ;Primary end point(s): Primary endpoints - Vaginal Pulse Amplitude (VPA) - Clitoral Blood Volume (CBV) - Subjective ratings of sexual functioning (questionnaires) | — |
Countries
Netherlands
Outcome results
None listed