Comparison of the pharmacokinetic profiles of separately administered sublingual testosterone followed by a sildenafil citrate tablet, versus sublingual testosterone and sildenafil citrate combined in a fixed-dose combination tablet

Phase 1

Completed

• Conditions: Hypoactive sexual desire disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN14616088
• Lead Sponsor: Emotional Brain BV

Brief Summary

2016 Results article in https://pubmed.ncbi.nlm.nih.gov/26804967/ (added 17/05/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-07-15
• Study Start: 2015-04-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 12

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

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 < 90 mmHg and/or diastolic blood pressure <50 mmHg
2. Gynecological and obstetric conditions:
2.1. Use of oral contraceptive containing anti-androgens
2.2. Use of oral contraceptive containing 50 ?g estrogen or more
2.3. Pregnancy or intention to become pregnant during this study (Note: All women were to undergo a urine pregnancy test prior to study entry)
2.4. Lactating or delivery in the previous 6 months
2.5. Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
2.6. Subjects with a perimenopausal hormonal status (follicle-stimulating hormone > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified