A study on the effect of testosterone and tadalafil on sexual in women with low sexual desire

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 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

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 6
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, 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. For subjects > 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure = 160 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.Positive test result for Chlamydia or Gonorrhea
9.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.)
10.Lactating or delivery in the previous 6 months
11.Significant abnormal pap smear in the previous 12 months
12.History of bilateral oophorectomy
13.Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
Other Medical Conditions
14.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)
15.Current clinically relevant endocrine disease or uncontrolled diabetes mellitus
16.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
17.History of hormone dependent malignancy
18.Vision impairment, such as partial or complete blindness or color blindness
19.Dyslexia
20.Positive test result for human immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
Psychological/Psychiatric Factors
21.History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered
22.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
23.Current psychotherapeutic treatment for female sexual dysfunction
24.Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).
25.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.
26.Positive test result for illicit drugs
Concomitant Medications
27.Use of potent CYP3A4 inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine, saquinavir and grapefruitjuice)
28.Use of potent CYP3A4 inducers (eg, carbamazepine, phenytoin, phenobarbital, St Johns Wort, rifampicin)
29.Use of nitrates or nitric oxide donor compounds
30.Use of SSRIs
31.Use of any other medication that interferes with study medication (eg, monoamine