E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypoactive sexual desire disorder and female sexual arousal disorder |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate effects of sexual arousal induced by an erotic film during treatment of testosterone combined with sildenafil on functional brain activity in healthy female subjects with and without FSD. |
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E.2.2 | Secondary objectives of the trial |
To evaluate effects of differing levels of attentional engagement on brain activity during erotic film viewing. To evaluate the interaction of differing levels of extraversion and cortisol reactivity on inhibitory brain activity during erotic film viewing. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects must have signed the Informed Consent Form. • Subjects must be between 21 and 45 years of age • Subjects must have experienced low sexual arousal for at least six months prior to study entry. The diagnosis will be made by an experienced sexologist. • Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically irrelevant. • Subjects must be premenopausal |
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E.4 | Principal exclusion criteria |
1. Use of oral contraception containing anti-androgens (Diane-pill). 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 of childbearing potential 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. 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). 9. History of neurological treatment or current neurological treatment. 10. History of psychiatric treatment or current psychiatric treatment. 11. History of childhood sexual abuse. 12. Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity. 13. History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months. No limiting or unstable angina pectoris. 14. No clinically relevant deviations in ECG parameters as judged by the medical investigator. 15. Use of medicinal herbs such as St John’s wort, Ginkgo Biloba and nutrition containing grapefruit. 16. Severe chronic or acute liver disease, impairment according to Child-Pugh categorization. 17. Exposure to nitric oxides. 18. 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. 19. Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices. 20. Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires. 21. 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. 22. Subjects who are claustrophobic |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess activity of functional brain regions related to testosterone induced sexual arousal. To assess the role of differing levels of attention toward sexual stimuli on activity of brain regions associated with sexual arousal. To evaluate the self-report ratings of sexual functioning. To evaluate teh effects of personality and cortisol reactivity. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last subject's follow-up visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |