problems with sexual functioning Sexual dysfunction
Conditions
Interventions
administration of sublingual testosterone (0.5 mg) and an oral tablet
containing tadalafil (10 mg)
Sponsors
Emotional Brain BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent 2.Female 21 to 45 years of age, inclusive, premenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained professional. 3.Heterosexual orientation 4.Be involved in a stable relationship 5.Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
Exclusion criteria
Exclusion criteria: Cardiovascular Conditions 1.Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity 2.History of myocardial infarction, stroke, transient ischemic attack or life threatening arrhythmia within the prior 6 months 3.Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG) 4.Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure > 90 mmHg 5.Systolic blood pressure 3 times the upper limit of normal and/or glomerular filtration rate < 29 mL/min based on the Cockcroft and Gault formula) 14.Current clinically relevant endocrine disease or uncontrolled diabetes mellitus 15.Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could form a contraindication for tadalafil and/or testosterone use 16.History of hormone dependent malignancy 17.Vision impairment, such as partial or complete blindness or color blindness 18.Dyslexia 19.Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection);Psychological/Psychiatric Factors 20.History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered 21.Treatment for a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for tadalafil and/or testosterone use 22.Current psychotherapeutic treatment for female sexual dysfunction 23.Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision). 24.A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject*s participation in the study. 25.Positive test result for illicit drugs;Concomitant Medications 26.Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine, saquinavir and grapefruitjuice) 27.Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St Johns Wort, rifampicin) 28.Use of nitrates or nitric oxide donor compounds 29.Use of SSRIs 30.Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid) 31.Use of medication (including herbs) that would compromise the validity of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the increase in sexual satisfaction of a single coital event, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ), and through a psychological interview discussing in depth (at follow up but whilst still blinded) the difference between two sexual events experienced at home whilst using study medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are as follows: • Physiological sexual response o VPA in response to erotic film clips o CBV in response to erotic film clips • Subjective sexual response o Subjective rating of sexual desire and arousal in response to an erotic film clip (SARSAQ) • Safety assessments | — |
Countries
Netherlands
Outcome results
None listed