problems with sexual functioning sexual dysfunction
Conditions
Interventions
None listed
Sponsors
Companion Diagnostics BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Females between 18 and 70 years of age, inclusive, pre or postmenopausal, with FSIAD (comorbidity with female orgasmic disorder [FOD]; only as secondary diagnosis) is allowed. The diagnosis of FSIAD will be established by a trained health care professional 3. Be involved in a stable, communicative, monogamous relationship and have a sexually functional partner who will be at home for a large part of the study duration 4. Healthy with normal medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant 5. Use of highly effective contraception
Exclusion criteria
Exclusion criteria: 1. Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity; 2. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg (supine blood pressure). 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; 3. Systolic blood pressure 40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms); 11. Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) 7.5%) 13. Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory; 14. Any current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results or which exclude from use of sildenafil, buspirone and/or testosterone; 15. History of hormone dependent malignancy (including all types of breast cancer); 16. Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection); 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 (other than those under inclusion criterion 6) that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for sildenafil, buspirone and/or testosterone use; 19. Current psychotherapeutic treatment for female sexual dysfunction; 20. Current genito-pelvic pain/penetration disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM 5). 21. A substa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from placebo in frequency of satisfactory sexual events, following study medication intake, measured by the Sexual Event Diary (SED), item 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change from placebo in experienced sexually-related personal distress, measured by the Female Sexual Distress Scale-Revised (FSDS-R), specifically item 13. • Evaluation of meaningful improvement during treatment period, measured by the single item Patient*s Global Impression of Improvement (PGI-I) • Evaluation of meaningful benefit of study medication during treatment period, measured by the single item Patient Benefit Evaluation (PBE) • Change from placebo in frequency of orgasms, following medication intake, measured by the SED • Change from placebo in sexual desire, following medication intake, measured by the SED • Change from placebo in physical arousal, following medication intake, measured by the SED • Change from placebo inmental arousal, following medication intake, measured by the SED • Change from placebo in sexual pleasure, following medication intake, measured by the SED | — |
Countries
Netherlands
Outcome results
None listed