A study to evaluate the different levels of attention and VALence direction for erotic stimuli, in relation to genital and subjective sexual arousal in healthy female subjects and healthy female subjects with female sexual dysfunction
| ISRCTN | ISRCTN74137878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74137878 |
| Protocol serial number | EB069 (VAL) |
| Sponsor | Emotional Brain B.V. (The Netherlands) |
| Funder | Emotional Brain B.V. (The Netherlands) |
- Submission date
- 23/08/2007
- Registration date
- 23/08/2007
- Last edited
- 19/09/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Emotional Brain BV
Almere
1311 RL
Netherlands
| Phone | +31 (0)36 546 8346 |
|---|---|
| d.vanham@emotionalbrain.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | VAL |
| Study objectives | In the present placebo controlled study we will investigate the influence of valence on attention when viewing visual erotic stimuli. Especially when under the treatment condition of testosterone with sildenafil. In addition, we will investigate the effects of testosterone in combination with sildenafil on vaginal and subjective sexual arousal induced by visual erotic stimuli in females with Female Sexual Dysfunction (FSD) and control subjects, for individual motivational and emotional differences (valence). In earlier study's we've found a distinction between groups that differ in colour naming of erotic words compared to neutral words. These two groups also differed in their benefit from testosterone combined with sildenafil. We expect that for some women this treatment, testosterone with sildenafil will work adequately. For the other group, we expect that negative sexual experiences and personality differences and therefore the negative/defensive motivational neural circuit is responsible for the more diffuse reaction to the treatment of testosterone and sildenafil, in women with FSD. |
| Ethics approval(s) | Ethics approval gained from the local ethics committee (Stichting Therapeutische Evaluatie Geneesmiddelen, Medische Etische Toetsingscommissie [STEGMETC]) on the 13th June 2007 (ref: R07-013). |
| Health condition(s) or problem(s) studied | Female sexual dysfunction |
| Intervention | 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 testosterone and sildenafil 50 mg Treatment P: placebo testosterone and placebo sildenafil The two treatments (A and P) will be randomised across the 120 subjects. Two different drug combinations will be given on separate days: (day 1) placebo, (day 2) sildenafil plus testosterone. Drug administration will be divided into two parts. Testosterone will be administered first. Two hours after testosterone administration, sildenafil (Viagra) will be administered. Testosterone will have a behavioural effect, increasing sexual desire and arousal, after four hours of intake. Sildenafil will have a physical effect, increasing blood flow to the genitals, after 1 hour of intake. It's duration is about six hours. Two separate experimental days are separated by a three to ten day period. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Testosterone, sildenafil |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. To evaluate the correlation between subjective ratings of sexual functioning and physiological sexual responses |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key 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, gynaecological examination, medical history, vital signs, pregnancy test and Electrocardiogram (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 Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (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, gynaecological examination, medical history, vital signs, pregnancy test and ECG, and by the scoring on the strooptask during familiarization trial |
| Key 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 oestrogen 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 six months 6. Previous prolapse and incontinence surgery affecting the vaginal wall 7. Women with other unexplained gynaecological 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 six months 13. Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate greater than 100 bpm), or other significant abnormality observed on Electrocardiogram (ECG) 14. Systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg. For subjects with age greater than 60 years and without diabetic mellitus, familiar hypercholesterolemia or cardiovascular disease: systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 90 mmHg (according to the CBO-guideline hypertension [CBO.2000a]) 15. Subjects who are taking strong CYP3A4-inhibitors: ritonavir (Human Immunodeficiency Virus [HIV] Protease inhibitor), ketoconazole and itraconazole 16. Subjects who are taking less strong CYP3A4-inhibitors: clarithromycin, erythromycine and saquinavir 17. Subjects who are taking CYP3A4-inducers: carbamazepine, phenytoin, phenobarbital, 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 behaviour 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 seven days before visit one 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 six months before the first experimental day |
| Date of first enrolment | 21/06/1978 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1311 RL
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |