problems with sexual functioning Sexual dysfunction
Conditions
Interventions
None listed
Sponsors
EB FlevoResearch BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study; 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures; 3. Females between 18 and 55 years of age (both inclusive); 4. Healthy based on medical history, physical examination, electrocardiogram, laboratory values and vital signs; 5. Body mass index (BMI) >=18 kg/m2 and
Exclusion criteria
Exclusion criteria: Cardiovascular conditions; 1. History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months; 2. Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality as observed on electrocardiogram (ECG); 3. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 4. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure< 50 mmHg; 5. Use of oral contraceptives containing anti-androgens (e.g. crypteron acetate) or anti (androgenic) progestogens (drosperidone, dienogest, chlormadinone acetate and norgestrel);6. Use of any hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen; 7. Pregnancy (note: an urine pregnancy test will be performed in all women prior to the administration of study medication); 8. Lactating or delivery in the previous 6 months; 9. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms (e.g. hot flashes, night contraceptive sweating) in combination with elevated FSH levels (>40 IU/L) for women age 40 onwards; in women with a history of hysterectomy, perimenopausality can be assessed by FSH levels (>40 IU/L) and/or vasomotor symptoms); 10. Liver and/or renal insufficiency; 11. Current clinically relevant endocrine disease; 12. Positive serology for HIV, Hepatitis B (surface antigen), and/or Hepatitis C; 13. Substance abuse disorder; 14. Use of nitrates or nitric oxide donor compounds; 15. Subjects who are taking potent CYP3A4 inhibitors or inducers; 16. Use of serotonergic drugs (e.g. Trazodon, fluvoxamide);17. Use of testosterone therapy within 6 months before study entry; 18. Use of any medication that interferes with study medication (e.g. monoamine oxidase (MAO) inhibitors, calcium channel blockers); 19. Illiteracy, unwillingness or inability to follow study procedures; 20. Participation in any other clinical drug study in the previous 3 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic 90% CI ratio for both AUCinf and Cmax | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Difference in Tmax and tlag and - Area under the concentration time curve (AUC) - Peak exposure (Cmax) - Time to peak exposure (Tmax) - Lag time (tlag) - Terminal elimination half-life (t*) Residual testosterone per tablet and rupture test analysis after: A. 30 sec sublingual administration B. 60 sec sublingual administration C. 90 sec sublingual administration D. 120 sec sublingual administration Safety E. Nature, frequency and severity of adverse events F. Vital signs and 12-lead ECG G. Safety laboratory tests (urinalysis, hematology, biochemistry) | — |
Countries
Netherlands
Outcome results
None listed