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Lybrido Food effect study Voedsel effect onderzoek naar Lybrido


- candidate number18308
- NTR NumberNTR4675
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2014
- Secondary IDsNL49313.056.14 CCMO
- Public TitleLybrido Food effect study Voedsel effect onderzoek naar Lybrido
- Scientific TitleA 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
- ACRONYMEB96
- hypothesisPrimary objective
1. To determine the effect of food on the pharmacokinetics of sildenafil administered as the Lybrido formulation
2. To determine whether >90% of the testosterone content is released after maximally 90 seconds after sublingual dosing
Secondary objective
1. To evaluate the safety and tolerability of a single dose of Lybrido under fasted and fed conditions
- Healt Condition(s) or Problem(s) studiedSexual function, Sexual dysfunction
- Inclusion criteria1. 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 criteriaCardiovascular 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

Gynecological and obstetric conditions
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 g/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)

Other medical conditions
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 Psychological and physiological factors
13. Substance abuse disorder Concomitant medication
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 study medication that interferes with study medication (e.g. monoamine oxidase (MAO) inhibitors, calcium channel blockers)

General
19. Illiteracy, unwillingness or inability to follow study procedures
20. Participation in any other clinical drug study in the previous 3 months
21. Smoking
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 23-jun-2014
- planned closingdate11-aug-2014
- Target number of participants18
- InterventionsLybrido 2 gifts
- Primary outcomePharmacokinetic 90% CI ratio for both AUCinf and Cmax
- Secondary outcomePharmacokinetic 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)
- TimepointsA total of 18 subjects receive the investigational drug on two experimental days.
- Trial web sitewww.emotionalbrain.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES J. Gerritsen
- CONTACT for SCIENTIFIC QUERIESDrs. K. Rooij, van
- Sponsor/Initiator EB FSD
- Funding
(Source(s) of Monetary or Material Support)
EB FSD
- Publications
- Brief summaryA total of 18 subjects receive the investigational drug. During the 2 experimental days (where bloodsampling for PK analysis will take place), subjects receive Lybrido under Fed and Fasted conditions in random order. Subjects visit the site total of 4 times: 1 screening visit, 1 experimental days for two times in a crossover (consisting of an admission,day 1 and day 2) and 1 final follow up visit.
- Main changes (audit trail)
- RECORD8-jul-2014 - 25-okt-2014


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