Female Sexual Dysfunction, FSD, Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder Sexueel disfunctioneren bij vrouwen Verminderd sexueel verlangen Verminderd sexuele opwinding bij vrouwen.
Conditions
Interventions
Testosterone, administered as a solution sublingually (0.5 mg) and sildenafil, type 5 phosphodiesterase (PDE5) inhibitor, administered as an encapsulated tablet orally (50 mg).
Treatment A: 0.5 mg te
Sponsors
Adriaan Tuiten
Emotional Brain BV
Eligibility
Inclusion criteria
Inclusion criteria: 40 Subjects must meet the following criteria: 1. Subjects must have a heterosexual orientation; 2. Subjects must be between 21 and 65 years of age; 3. Subjects with normal sexual functioning; 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. 80 Subjects must meet the following criteria: 1. Subjects must have a heterosexual 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, but not limited to, a physical examination, gynecological examination, medical history, vital signs, pregnancy test and ECG, and by the scoring on the strooptask during familiarization trial.
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 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 particip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluation of 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 Female Sexual Dysfunction. Data for analysis: a. Attention for erotic stimuli (strooptask: speedrate). A masked version of the Emotional Stroop Task comparing colour-naming latencies on neutral and erotic words will be used. The word is presented before and after the erotic film excerpts in the attention condition for about 24 ms and then masked by randomly cut, reassembled signs in the same colour (red, green, yellow or blue). The colour of the mask has to be assigned, and subjects are asked to verbally name the colours as quickly as possible. The stimuli are presented in the centre of the screen. An extra set of stimuli will be prepared for practice-trials. A trial consists of a fixation point, which will be shown for 750 ms, followed by the target stimulus (the coloured neutral or erotic word and mask). Vocal responses will be recorded and will terminate the trials. The order of these 2 blocks will be randomly assigned. Attention will be measured on both the experimental days in the morning (pre-dose) and in the afternoon (post-dose). b. Vaginal Pulse Amplitude (VPA) A vaginal photoplethysmograph will be used to measure Vaginal Pulse Amplitude (VPA) (the AC component of the signal), which is a reliable index for genital vasocongestion. Changes in the amplitude of the signal reflect changes in vaginal vasocongestion. The vaginal photoplethysmograph (VP) is a clean tampon shaped device, which contains an infrared light-emitting diode (LED) as a light source and a photosensitive light detector (photodiode). It measures the blood volume in the tissue surrounding the plethysmograph. The light emitted by the LED is reflected by the blood vess | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the correlation between subjective ratings of sexual functioning and physiological sexual responses. 2. To evaluate the changes in differences in direction of valence when viewing visual erotic stimuli under the placebo condition and the condition with testosterone combined with sildenafil. 3. To evaluate the individual differences in attention in relation to positive and/or negative valence induced by visual erotic stimuli. 4. To evaluate the influence of personality traits on the differences in vaginal & subjective sexual arousal, EMG, valence direction and startle reflex. 5. Subjective ratings of sexual functioning. 6. Startle reflex; 7. EMG activation; 8. Personality traits; 9. Negative sexual experiences will be assesed with a questionnaire and in the clinical interview, both during screening. | — |
Contacts
Public ContactD. Ham, van
Emotional Brain BV
Outcome results
None listed