Hypoactive Sexual Desire Disorder Sexual Interest/Arousal Disorder MedDRA version: 14.1 Level: LLT Classification code 10037228 Term: Psychosexual dysfunction with inhibited sexual desire System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10059272 Term: Sexual desire decreased System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 14.1 Level: LLT Classification code 10040465 Term: Sexual arousal decreased System Organ Class:
Conditions
Interventions
Product Name: Buspirone
Product Code: Buspirone
Pharmaceutical Form: Tablet
INN or Proposed INN: BUSPIRONE
CAS Number: 36505-84-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Emotional Brain BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed). The diagnosis will be made by an experienced psychologist/sexologist. 3. Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically irrelevant. 4. Subjects must have a heterosexual relationship. 5. Be involved in a stable relationship and have a partner who will be accessible during the 3-week at home period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cardiovascular conditions 1. Any underlying cardiovascular condition, including unstable angina pectoris 2. Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg. 3. Systolic blood pressure 40) Other medical conditions 10. Liver- and/or renal insufficiency 11. Current clinically relevant endocrine disease 12. Current clinically relevant neurological disease which, in the opinion of investigator, would compromise the validity of study results, or which could form a contraindication for buspirone and/or testosterone use 13. (A history of) hormone-dependant malignancy 14. Vision impairment, such as partial or complete blindness or color blindness 15. Dyslexia 16. Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection) Psychological/psychiatric factors 17. History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered 18. (Psychotherapeutic and/or pharmacological 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 buspirone and/or testosterone use 19. Current psychotherapeutic treatment for female sexual dysfunction 20. Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision (DSM IV TR)) 21. 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 (mild or moderate alcohol consumption is allowed but must be stopped 12 hours before the Stroop task). 22. Positive test result for illicit drugs Concomitant medication 23. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir) 24. Subjects who are taking CYP3A4-inducers (eg, carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine) 25. Use of serotonergic drugs (eg, trazodon, fluvoxamine), tricyclic antidepressants or other antidepressants 26. Use of testosterone therapy within 6 months before study entry 27. Use of any other medication that interferes with study medication (eg, monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (eg, diltiazem and verapamil), triptans) General 28. Illiteracy, unwillingness, or inability to follow study procedures 29. Any other clinically significant abnormality or condition which, in the opinion of investigator, might interfere with the p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in increasing vaginal pulse amplitude (VPA), clitoral blood volume (CBV) and subjective ratings of sexual desire and arousal in the laboratory, in healthy female subjects with hypoactive sexual desire disorder (HSDD).;Main Objective: To investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in increasing sexual satisfaction during sexual activity in the domestic setting in healthy female subjects with hypoactive sexual desire disorder (HSDD).;Primary end point(s): The primary endpoint is the increase in sexual satisfaction of a single coital event, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ).;Timepoint(s) of evaluation of this end point: 3 measurements at home within a 3-week period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 (as defined in Section 4.3.4.2) ;Timepoint(s) of evaluation of this end point: 3 psychophysiological measurements in the laboratory within a 2-week period | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Manager J. Gerritsen
Emotional Brain BV
Outcome results
None listed