A study to investigate the subjective and fysiological effects of the combined administration of testosterone and buspirone and buspirone administration alone in women with decreased sexual desire

Conditions: Hypoactive Sexual Desire DisorderSexual Interest/Arousal Disorder
MedDRA version: 14.1Level: LLTClassification code 10040465Term: Sexual arousal decreasedSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: LLTClassification code 10037228Term: Psychosexual dysfunction with inhibited sexual desireSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorderSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: PTClassification code 10062641Term: Female sexual arousal disorderSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
MedDRA version: 14.1Level: HLTClassification code 10040470Term: Sexual desire disordersSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: PTClassification code 10058929Term: Disturbance in sexual arousalSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: HLTClassification code 10040466Term: Sexual arousal disordersSystem Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 14.1Level: LLTClassification code 10059272Term: Sexual desire decreasedSystem Organ Class: 10037175 - Psychiatric disorders

Registration Number: EUCTR2012-003543-30-NL

Lead Sponsor: Emotional Brain BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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

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 < 90 mmHg and/or diastolic blood pressure <50 mmHg

Gynecological and obstetric conditions
4.Use of oral contraceptive containing anti-androgens (e.g. Crypteron acetate) or (anti)androgenic progestogens (drospirone, dienogest, chlormadinone acetate and norgestrel)
5.Use of oral contraceptive containing 50 µg estrogen or more
6.Pregnancy or intention to become pregnant during this study (Note: An urine pregnancy test will be performed in all women prior to the administration of study medications.)
7.Lactating or delivery in the previous 6 months
8.Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
9.Subjects with a perimenopausal hormonal status (follicle-stimulating hormone>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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): •Physiological sexual response<br>oVPA in response to erotic film clips<br>oCBV in response to erotic film clips<br>•Subjective sexual response<br>oSubjective rating of sexual desire and arousal in response to an erotic film clip (SARSAQ)<br>•Safety assessments (as defined in Section 4.3.4.2)<br>;Timepoint(s) of evaluation of this end point: 3 psychophysiological measurements in the laboratory within a 2-week period