E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Female Sexual Dysfunction, specifically Hypoactive Sexual Desire Disorder, with or without Female Sexual Arousal Disorder. |
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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 | 10020933 |
E.1.2 | Term | Hypoactive sexual desire 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 objective: To evaluate efficacy of Lybridos on physiological and subjective indices of sexual arousal in healthy female subjects with Female Sexual Dysfunction.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: - To investigate Lybridos’ influence on attentional bias for erotic stimuli. - To evaluate the safety of Lybridos.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Thirteen (13) premenopausal and postmenopausal women with Hypoactive Sexual Desire Disorder (HSDD), with or without Female Sexual Arousal Disorder (FSAD).
Additionally, subjects must meet the following criteria: 1 Subjects must have a heterosexual orientation. 2 Subjects must be between 21 and 70 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 Stroop task during familiarization trial.
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E.4 | Principal 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 moderate or severe neurological complaints or current moderate or severe neurological complaints and/or treatment for current moderate or severe neurological complaints; 10 History of moderate or severe psychiatric complaints or current moderate or severe psychiatric complaints and/or treatment for current moderate or severe psychiatric complaints; 11 History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months; 12 Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm), or other significant abnormality observed on ECG; 13 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)). Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg 14 Subjects who are taking strong CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol 15 Subjects who are taking less strong CYP3A4-inhibitors: claritromycine, erytromycine en saquinavir 16 Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine 17 Severe chronic or acute liver disease, history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment; 18 Use of medicinal herb as Ginkgo Biloba, St John's wort and nutrition containing grapefruit; avoid valerian, gotu kola, kava kava (may increase CNS depression) 19 Subjects who are taking MAO inhibitors (includes classic MAO inhibitors and linezolid), Calcium channel blockers (e.g. Diltiazem and verapamil), Nefazodone, SSRIs, TCAs, Tramadol; 20 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. 21 Use of any treatment for FSD within the 7 days before visit 1 or during the study, including oral medications or constrictive devices; 22 Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires; 23 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; 24 Subjects who are experiencing vision impairment, like partial or complete blindness or color blindness; 25 Subjects with a peri menopausal hormonal status; 26 Subjects with a body mass index (BMI)>35 kg/m2
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints - Vaginal Pulse Amplitude (VPA) - Clitoral Blood Volume (CBV) - Subjective ratings of sexual functioning (questionnaires)
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 0 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |