E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
low sexual desire and arousal |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
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 |
The aim of the study is: to investigate the effect of DCS on the physiological and subjective correlates reflecting conditioned sexual response, and sexual memory formation.
Hypothesis: We hypothesize that administration of DCS after a classical conditioning procedure will enhance sexual memory formation of conditioned sexual responses. Compared to the placebo-condition, for the DCS condition an increase in sexual conditioned responses elicited by reward-conditioned cues will be seen on a test phase 24hrs later. The DCS condition will show stronger conditioned genital and subjective responding, also outside the original acquisition context, compared to the placebo condition.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For this study we will include 68 healthy sexually functional women between 18-45 years. Participants will be included if they have had no sexual complaints for at least one year, and are sexually active. |
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E.4 | Principal exclusion criteria |
- Age < 18 or > 45 years - Homosexual orientation - Pregnancy or lactation - Colour blindness - A diagnosis of affective, psychotic or substance related disorder according to DSM 5. - Current or recurrent use (less than 4 weeks before participation) of medication that may affect sexual response. To determine possible sexual side-effects the 'Farmacotherapeutisch kompas' 2015 will be used. - Current or previous disorders of the genitals or treatments for such disorders that may influence the sexual response or the measurement of the response. - Other medical disorders that may influence the sexual response or the measurement of the response. - Current or recurrent use (less than 4 weeks before participation) of medication that may affect or interact with the effects of DCS. To determine possible contra-indications, instructions for use as supplied by 'King Pharmaceuticals' will be used. - Current or previous disorders (like severe anxiety or psychosis, liver disease or severe renal insufficiency, epilepsy) that increase the possibility of side effects of DCS and for which usage of DCS is contraindicated. - Alcohol or drug use on the night and day before participation, as well as alcohol and drug use between test moments (day 1 and day 2). |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) measures of vaginal pulse amplitude (VPA) assessed by a vaginal photoplethysmograph; 2) Subjective ratings of US expectancy, affective valence and sexual arousal; 3) implicit attitude |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
The aim of the study is: to investigate the effect of DCS on the physiological and subjective correlates reflecting conditioned sexual response. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |