A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of sildenafil after a single oral administration of Lybrido in healthy female subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

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 <= 30 kg/m2;
6. Venous access sufficient to allow blood sampling as per protocol;

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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic<br /><br>90% CI ratio for both AUCinf and Cmax</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic<br /><br>Difference in Tmax and tlag<br /><br>and<br /><br>- Area under the concentration time curve (AUC)<br /><br>- Peak exposure (Cmax)<br /><br>- Time to peak exposure (Tmax)<br /><br>- Lag time (tlag)<br /><br>- Terminal elimination half-life (t*)<br /><br><br /><br>Residual testosterone per tablet and rupture test analysis after:<br /><br>A. 30 sec sublingual administration<br /><br>B. 60 sec sublingual administration<br /><br>C. 90 sec sublingual administration<br /><br>D. 120 sec sublingual administration<br /><br><br /><br>Safety<br /><br>E. Nature, frequency and severity of adverse events<br /><br>F. Vital signs and 12-lead ECG<br /><br>G. Safety laboratory tests (urinalysis, hematology, biochemistry)</p><br>