A single blind, randomized, cross-over placebo controlled dose finding study to investigate the pharmacokinetic profile of 3 doses of sublingual testosterone solution and their effect on physiological and subjective arousal in healthy, sexually functional premenopausal women. - PK-PD testosterone

• Conditions: This pharmacokinetic trial will be conducted in healthy women, but it is a part of a developmental program for medicine for Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed); MedDRA version: 12.1Level: HLTClassification code 10040466Term: Sexual arousal disorders; MedDRA version: 12.1Level: HLTClassification code 10040470Term: Sexual desire disorders; MedDRA version: 12.1Level: HLTClassification code 10040478Term: Sexual dysfunction NEC; MedDRA version: 12.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorder; MedDRA version: 12.1Level: LLTClassification code 10037228Term: Psychosexual dysfunction with inhibited sexual desire; MedDRA version: 12.1Level: LLTClassification code 10059272Term: Sexual desire decreased; MedDRA version: 12.1Level: LLTClassification code 10040465Term: Sexual arousal decreased; MedDRA version: 12.1Level: LLTClassification code 10058929Term: Disturbance in sexual arousal; MedDRA version: 12.1Level: LLTClassification code 10062641Term: Female sexual arousal disorder

• Registration Number: EUCTR2010-019285-86-NL
• Lead Sponsor: Emotional Brain

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-25
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

-Healthy sexually functional premenopausal women.
-Provision of written informed consent;
-Female 21-40 years of age;
-Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically relevant;
-Subject must be heterosexually oriented;
-Venous access sufficient to allow blood sampling as per protocol.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1Sexual dysfunction as determined SFQ diagnostic scores (within ‘high probability of dysfunction’ or ‘possibility of dysfunction’ ranges) for all functional domains (desire, arousal-lubrication, arousal-sensation, orgasm and pain) as described by Quirk et al. 2005;
2Subjects who had used testosterone therapy within 6 months before study entry;
3(A history of) hormone-dependant malignancy ;
4Use of oral contraception containing anti-androgens (e.g. Diane 35; Minerva);
5Use of oral contraception containing 50 µg estrogen or more;
6Pregnancy, or intention to become pregnant during this study (Note: a serum or urine pregnancy test will be performed in all women prior to the administration of study medications);
7A pelvic inflammatory disease or an untreated vaginal infection at screening;
8Lactating, or subjects who have given birth in the previous 6 months;
9Previous prolapse and incontinence surgery affecting the vaginal wall, which in the opinion of investigator would interfere with the VPA measurement;
10Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;
11(History of) endocrine disease;
12(History of) severe neurological problems, current severe neurological problems, or other mild or moderate neurological problems which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if she took part in the trial;
13Treatment for a current serious psychiatric disorder (e.g., schizophrenia, psychosis ) or treatment for obsessive compulsive disorder, anorexia nervosa, bulimia nervosa and/or social anxiety neurosis.
14Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;
15(History of) myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
16Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 60-80 bpm in rest, > 90-115 bpm in moderate exercise), or other significant abnormality observed on ECG;
17Systolic blood pressure = 130 mmHg and/or diastolic blood pressure > 80 mmHg;
18Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;
19Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;
20Acute/chronic liver disease: ASAT and ALAT > 3x the upper limit of normal;
21Renal insufficiency (< 29 ml/min): based on the Cockcroft and Gault formula;
22A 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 moderately alcohol drinking behavior is allowed, only 12 hours before the experimental days is alcohol drinking not allowed. Three weeks before the start of the experimental day is the taking of any recreational drug not allowed. Smoking is allowed.
23Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;
24Any other clinically significant abnormality or condition which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified