E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hypoactive sexual desire disorder in women (HSDD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062641 |
E.1.2 | Term | Female sexual arousal disorder |
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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 |
Primary objectives 1. Test which measures or combination of measures, selected for their likelihood of tapping the domain of sexual desire broadly, best detect acute changes in sexual desire in women who have no sexual dysfunction vs. those reporting HSDD. 2. Test sensitivity and precision of these measures for detecting desire changes in response to a selected agent with past evidence of causing acute changes in sexual desire/arousal. 3. Test the Acute Female Sexual Desire Scale for its ability to summarize sexual arousal changes occurring in the laboratory setting and outside.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives 1. Begin to develop subtypes of sexual desire problems in women, particularly ‘general’ and ‘partner specific’. 2. Examine differences between pre and postmenopausal women regarding the usefulness of each measure or combination of measures to detect desire changes. 3. Examine differences, consistencies between lab experience and following 24 hours in terms of sexual desire and behaviour. 4. Predict those women who are desire ‘responders’ in the lab, using demographic, hormonal status (per lab values) and selected sexuality variables. 5. Study test-retest reliability by calculating correlations between the first and second visit and third and fourth visit for the primary objectives
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for all women are: being in a stable relationship; being in general good health; having a hetero- or bisexual orientation; using a reliable form of contraception. Inclusion criteria for HSDD women are: aged between 18-45 (premenopausal) and 50-65 (postmenopausal), minimally 6 months complaints of HSDD; HSDD participants may also be experiencing arousal and orgasm problems (except for sexual pain problems), but the HSDD must be the primary problem. Inclusion-criterion for SF women is: aged between 18-45 (premenopausal); no sexual complaints during the past 6 months |
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E.4 | Principal exclusion criteria |
Exclusion criteria for all women are: medications that would interfere with sexual functioning; illness or disease interfering with sexual functioning (including diabetes, cancer in the past 5 years); active depression, pregnancy or the intent to become pregnant; sexual problems in the woman’s partner, that make sexual activity impossible; postmenopausal women on hormone replacement therapy; vaginal procedures that might interfere with vaginal vascularisation and/or innervation of vaginal tissue. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Level of sexual desire as assessed with questionnaires and tasks during which participants have to judge sexual stimuli. Reaction times and number of errors as assessed with implicit tasks. Genital arousal responses (VPA) as assessed with vaginal photoplethysmograpy and subjective ratings of sexual arousal as assessed with questions while being exposed to sexual stimuli. Acoustic Startle Reflex (ASR) as measure for approach to/avoidance of sexual stimuli. Additionally, the effects of testosterone gel on abovementioned variables will be measured in women with HSDD. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
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 |
test sensitivity of investig. measures for detecting changes to drug known to evoke sex. desire |
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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) | 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 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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the end of the trial will be as soon as the last subject has had her final visit in the second fase of the study |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |