Hypoactive Sexual Desire Disorder/SSRI-induced sexual dysfunction MedDRA version: 14.1 Level: HLT Classification code 10040470 Term: Sexual desire disorders System Organ Class: 100000004873 MedDRA version: 14.1 Level: LLT Classification code 10020933 Term: Hypoactive sexual desire disorder System Organ Class: 100000004873
Conditions
Interventions
Product Name: Lybrido
Product Code: Lybrido
Pharmaceutical Form: Coated tablet
INN or Proposed INN: TESTOSTERONE
Other descriptive name: testosterone
Concentration unit: mg milligram(s)
Concentration
Sponsors
Companion Diagnostics BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent 2. Females between 18 and 70 years of age, inclusive, pre or postmenopausal, with HSDD or SSRI induced sexual dysfunction (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD]; only as secondary diagnosis) is allowed. The diagnosis of HSDD or SSRI induced sexual dysfunction 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 the majority 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 6. For women who use SSRI: usage of an SSRI for the treatment of anxiety disorders or depression (not for, for example, anorexia nervosa or obsessive compulsive disorder) for a minimum of 3 months and on a stable dose for at least 6 weeks before screening. The following dosage ranges are allowed: Prozac (fluoxetine) 20-80 mg/day; fluvoxamine 100-300 mg/day; Zoloft (sertraline) 50-200 mg/day; Paxil (paroxetine) 20-60 mg/day; Celexa (citalopram) 20-40 mg/day; Lexapro (escitalopram) 10-30 mg/day 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 205 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
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 = 90 mmHg and/or diastolic blood pressure = 50 mmHg (supine blood pressure). 4. Use of any contraceptive containing anti-androgens or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel) 5. Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen 6. Pregnancy or intention to become pregnant during this study 7. Lactating or delivery in the previous 6 months prior to signing Informed Consent Form 8. History of bilateral oophorectomy 9. Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns 10. Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms and/or FSH levels (>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 (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL) 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 serotonin syndrome Psychological/Psychiatric Factors 18. History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered 19. (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 20. Current psychotherapeutic treatment for female sexual dysfunction 21. Current sexual disorder of vaginismus or dyspareunia according to the DSM IV TR, Anorgasmia with a lifelong inability to reach an orgasm 22. 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 23. For women who use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To validate the existing diagnostic model which predicts the sensitivity to Lybrido or Lybridos in women with HSDD (with or without FSAD and/or FOD as secondary diagnosis), measured by the number of satisfactory sexual events. • To identify additional psychometric and biological markers for the diagnostic model in order to increase predictive power for sensitivity to Lybrido or Lybridos in women with HSDD (with or without FSAD and/or FOD as secondary diagnosis), measured by the number of satisfactory sexual events. • To evaluate/validate the altered diagnostic model in women with HSDD (with or without FSAD and/or FOD as secondary diagnosis), measured by the number of satisfactory sexual events. • To identify psychometric and biological markers to predict the sensitivity to Lybrido or Lybridos in women with SSRI-induced sexual dysfunction, measured by the number of satisfactory sexual events. ;Secondary Objective: • To identify the optimal dose of Lybridos (Lybridos-10 vs Lybridos-20) in women with HSDD (with or without FSAD and/or FOD). • To identify the optimal dose of Lybridos (Lybridos-10 vs Lybridos-20) in women with SSRI induced sexual dysfunction. ;Primary end point(s): The primary endpoint is the number of satisfactory sexual episodes, measured using the Sexual Satisfaction of an Event Questionnaire (SSEQ). ;Timepoint(s) of evaluation of this end point: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sexual satisfaction o SSEQ Sexual desire/arousal o Sexual Anamnesis Questionnaire-Improvement (SAQ I) o Sexual Function Questionnaire (SFQ) o Weekly diary Subjective evaluation of gain and improvement o Subjective Evaluation of Gain (SEG) questionnaire o Subjective Evaluation of Improvement (SEI) questionnaire Sexual Distress o Female Sexual Distress Scale –revised (FSDS-R) o Modified version of Sexual Anamnesis Questionnaire (SAQ) Profile of mood state o Profile of Mood State (POMS) questionnaire Safety assessments ;Timepoint(s) of evaluation of this end point: All endpoints: End of study | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Companion Diagnostics BV
Outcome results
None listed