A double-blind, randomized, placebo-controlled, proof of concept study to investigate the safety and efficacy of the combined administration of 0.5 mg sublingual testosterone and 10 mg tadalafil in women with hypoactive sexual desire disorder

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

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

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 < 90 mmHg and/or diastolic blood pressure < 50 mmHg;Gynecological and Obstetric Conditions
6.Use of oral contraceptive containing anti androgens
7.Use of oral contraceptive containing 50 µg estrogen or more
8.Pregnancy or intention to become pregnant during this study (Note: A urine pregnancy test will be performed in all women prior to the administration of study medications.)
9.Lactating or delivery in the previous 6 months
10.Significant abnormal pap smear in the previous 12 months
11.History of bilateral oophorectomy
12.Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns;Other Medical Conditions
13.Liver and/or renal insufficiency (aspartate aminotransferase and alanine aminotransferase > 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the increase in sexual satisfaction of a single coital<br /><br>event, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ),<br /><br>and through a psychological interview discussing in depth (at follow up but<br /><br>whilst still blinded) the difference between two sexual events experienced at<br /><br>home whilst using study medication.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are as follows:<br /><br>• Physiological sexual response<br /><br>o VPA in response to erotic film clips<br /><br>o CBV in response to erotic film clips<br /><br>• Subjective sexual response<br /><br>o Subjective rating of sexual desire and arousal in response to an erotic film<br /><br>clip (SARSAQ)<br /><br>• Safety assessments</p><br>