Hypoactive sexual desire disorder and female sexual arousal disorder
Conditions
Interventions
Product Name: Libifem
Product Code: Libifem
Pharmaceutical Form: Capsule*
INN or Proposed INN: Testosterone
CAS Number: 58-22-0
Current Sponsor code: testosterone sublingual
Concentration unit: mg mil
Sponsors
Emotional Brain BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Subjects must have a heterosexual orientation or secondary bisexual orientation 2 Subjects must be between 21 and 65 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 a, but not limited to, physical examination (including a gynecological examination), medical history, vital signs, pregnancy test and ECG, and by the scoring on the strooptask 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 neurological treatment or current neurological treatment; 10 History of serious psychiatric treatment or current psychiatric treatment; 11 Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity; 12 History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months; 13 Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG; 14 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)). 15 Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol 16 Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir 17 Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine 18 Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment; 19 Use of medicinal herb as Ginkgo Biloba and nutrition containing grapefruit; 20 Subjects who are taking nitrates or nitric oxide donors; 21 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. 22 Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices; 23 Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires; 24 Any other clinically significant abnormality or condition which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if she took part in the trial; 25 Moderate and severe hearing impairment; 26 Subjects who are colour blinded. 27 Subjects who are having botox® (or other equivalents of botox, like dysport) in the facial area within 6 months before the first experimental da
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the women’s judgment of valence (negative or positive) for erotic stimuli under placebo condition and the condition of 0.5 mg sublingual testosterone combined with sildenafil (50 mg) and the influence of positive and/or negative valence on attention for erotic cues, in healthy female subjects with and without FSD;Secondary Objective: - To evaluate the correlation between subjective ratings of sexual functioning and physiological sexual responses - To evaluate differences in direction of valence when viewing visual erotic stimuli in the placebo condition and the condition with testosterone combined with sildenafil, in healthy female subjects and healthy female subjects with FSD - To evaluate the genital and subjective arousal induced by visual erotic stimuli in female subjects with and without FSD in relation to individual differences in attention and positive and/or negative valence - To evaluate the influence of personality traits on the differences in vaginal & subjective sexual arousal, EMG, valence and startle reflex ;Primary end point(s): The distinction of subgroups in females with Female Sexual Dysfunction in order to determine the differential effectiveness of testosterone combined with sildenafil | — |
Countries
Netherlands
Outcome results
None listed