Hypoactive sexual desire disorder Mental and Behavioural Disorders
Conditions
Interventions
1. Testosterone (0.5mg) and sildenafil (50mg) administered separately as a solution containing testosterone for sublingual administration followed 2 1/2 hours later by a tablet containing sildenafil f
Sponsors
Emotional Brain BV
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Subject had to fulfill all of the following criteria to be enrolled into the study: 1. Provide written informed consent 2. Be female, between 18 and 35 years of age inclusive 3. Be healthy based on medical history, physical examination, laboratory values and vital signs 4. Have a body mass index (BMI) ? 18 kg/m2 and ? 30 kg/m2 5. Have sufficient venous access to allow blood draws
Exclusion criteria
Exclusion criteria: Subjects could not be entered into the study if any of the following criteria were met: 1. Cardiovascular conditions: 1.1. Any underlying cardiovascular condition, including unstable angina pectoris 1.2. History of myocardial infarction, stroke, or life-threatening arrhythmia within 6 months prior to study entry 1.3. Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG) 1.4. Systolic blood pressure ? 140 mmHg and/or diastolic blood pressure > 90 mmHg 1.5. Systolic blood pressure 30) 3. Other medical conditions: 3.1. Liver and/or renal insufficiency 3.2. Current clinically relevant endocrine disease 3.3 Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could constitute a contraindication for sildenafil and/or testosterone use 3.4. History of hormone-dependent malignancy 4. Psychological/psychiatric factors: 4.1. A substance abuse disorder that, in the opinion of the investigator, was likely to affect the subject’s ability to complete the study or preclude the subject’s participation in the study; mild or moderate alcohol consumption was allowed but had to be stopped 24 hours before the admission period until follow up. Smokers were not allowed to participate. 5. Concomitant medication: 5.1. Subjects who were taking CYP3A4-inhibitors (e.g., ritonavir, ketoconazole, itraconazol claritromycine, erytromycine and saquinavir) 5.2. Subjects who were taking CYP3A4-inducers (e.g., carbamazepine, fenytoinefenobarbital, St Johns Wort, rifampicine) 5.3. Use of nitrates or nitric oxide donor compounds 5.4. Use of any other medication that could interfere with study medication (e.g., monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (e.g., diltiazem and verapamil), use of corticosteroids) 5.5. Use of testosterone therapy within 6 months before study entry 6. Drug/food interaction 6.1. Consumption of grapefruit or grapefruit-containing foods throughout the duration of the study 7. General: 7.1. Illiteracy, unwillingness, or inability to follow study procedures 7.2. Any other clinically significant abnormality or condition which, in the opinion of the investigator, might interfere with the subject’s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication of sildenafil and/or testosterone use 7.3. Participation in any other clinical drug study in the previous 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters for total testosterone, free testosterone and dihydrotestosterone as well as for sildenafil and Ndesmethyl-sildenafil: 1. Maximum concentration (Cmax) 2. Area under the plasma concentration curve (AUC0-infinity/ AUC0-1590) 3. Time to Cmax (Tmax) The total testosterone and dihydrotestosterone were analyzed in plasma in a combination assay using High Performance Liquid Chromatography Tandem Mass Spectrometry (HPLCMS/MS). Free testosterone was determined in plasma through ultra filtration followed by LCMS/MS. Incurred sample reanalysis was performed in 5% of all samples. The existing method of analysis has been validated in a prior study. The analytes Sildenafil and N-desmethyl-sildenafil in human plasma were determined by means of a HPLC-MS/MS. Incurred sample reanalysis was performed in 10% of all samples. Samples were analysed using a mobile phase containing water, methanol and 0.1% acetic acid. The analytical column Hypersil GOLD (Thermo Scientific), dimension 50 x 2.1 mm, particle size 3 µm was used. An API-4000 triple quadrupole tandem mass spectrometer (Applied Biosystems) was used as the detector. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessments including: 1. Standard clinical chemistry, hematology and serology tests 2. Vital signs 3. Electrocardiogram (ECG) 4. Body temperature 5. Physical examination | — |
Countries
Netherlands
Outcome results
None listed