A double blind, randomized, cross-over placebo controlled study to investigate the efficacy of sublingual testosterone solution on physiological and subjective arousal in healthy, sexually dysfunctional premenopausal women.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

1. Provision of written informed consent;
2. Female 21-40 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed).
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 relevant;
4. Subject must be heterosexually oriented;
5. BMI >= 18 and <= 30 kg/m2.

Exclusion Criteria

1. A history of Childhood Sexual Abuse;
2. Subjects who had used testosterone therapy within 6 months before study entry;
3. Use of oral contraception containing anti-androgens (e.g. Diane 35; Minerva);
4. Use of oral contraception containing 50 µg estrogen or more;
5. Pregnancy, 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);
6. Lactating, or subjects who have given birth in the previous 6 months;
7. Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;
8. Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;
9. 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 moderately alcohol drinking behavior is allowed, only 24 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.
10. Subjects with a peri menopausal hormonal status (FSH > 30).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints<br /><br>• Vaginal Pulse Amplitude (VPA): difference between pre- and post dose<br /><br>relative increases to erotic stimuli (as compared to neutral stimuli) between<br /><br>treatments (placebo vs. 0.5 mg testosterone).<br /><br>• SARSAQ questionnaire: difference between pre- and post dose increases to<br /><br>erotic stimuli (as compared to neutral stimuli) between treatments (placebo vs.<br /><br>0.5 mg).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>• VPA: difference between different post dose measurement times (150 min vs.<br /><br>240 min. vs. 330 min) in primary endpoints.<br /><br>• SARSAQ questionnaire: difference between different post dose measurement<br /><br>times (150 min vs. 240 min. vs. 330 min) in primary endpoints.<br /><br>• Clitoral Blood Volume (CBV): as VPA described in primary & secondary<br /><br>endpoints.</p><br>

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