HSDD and SA MedDRA version: 12.1 Level: LLT Classification code 10020933 Term: Hypoactive sexual desire disorder
Conditions
Interventions
Product Name: Intranasal Testosterone Gel
Product Code: TBS-2
Pharmaceutical Form: Nasal gel
INN or Proposed INN: Testosterone
CAS Number: 58-22-0
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
Trimel Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis and inclusion criteria: HSDD - Females up to 65 years. - HSDD with personal distress (A score of “15” or higher on the FSDS-R) -? - BMI ? 35. - Women must have a score of >11 on the FSDS-R© at the Screen Visit together with a score of 11 on the FSDS-R© at the Screen Visit together with a score of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: HSDD - History of any clinically relevant other psychiatric disorders that could impact sexual function, risks patient's safety, or may impact compliance. - History of Major Depressive Disorder within 6 months prior the Screening Visit. - Patients who meet DSM-IV criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction due to a General Medical Condition. - Patients with pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. - Women with relationship discord as indicated by a score of > 20 on the Maudsley Marital Questionnaire. - Treatment with selective serotonin re-uptake inhibitors. - Treatment with systemic glucocorticoids. - Treatment with sex steroid hormones such as androgens, estrogens other than in low dose combined ET/P, or gestagens. - Treatment with thyroid hormones. - Significant intercurrent disease of any type, in particular liver, kidney, or heart disease, any form of diabetes mellitus or psychiatric illness. - History of nasal disorders or sleep apnea. - Patients with a history of dementia or other neurodegenerative diseases, organic brain disease, stroke, transient ischemic attacks, brain surgery, significant brain trauma, multiple sclerosis, spinal cord injury, peripheral neuropathy, and epilepsy. - History of cancer, excluding skin cancer. - History of severe or multiple allergies, severe adverse drug reaction or leucopenia. - History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation, or a history of Hepatitis B, a positive test for Hepatitis B surface antigen, a history of Hepatitis C, a positive test for Hepatitis C antibody, a history of HIV infection or demonstration of HIV antibodies. - History of sleeping problems, shift-workers. - Regular drinkers of more than 3 units of alcohol daily. - History of, or current evidence of, abuse of alcohol or any drug substance. - Difficulty in abstaining from OTC medication for the duration of the study. - Poor compliers or subjects unlikely to attend study visits. - Receipt of any drug as part of a research study within 30 days of initial dose administration. - Blood donation 12 week before the initial study dose. SA - History of any other clinically relevant psychiatric disorders that could impact sexual function, risks patient's safety, or may impact compliance. - History of Major Depressive Disorder within 6 months prior the Screen Visit. - Patients who meet DSM-IV criteria for Sexual Aversion Disorder, Substance-Induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia, or for Sexual Dysfunction Due to a General Medical Condition. - Patients experiencing relational discord as indicated by a score of > 20 on the Maudsley Marital Questionnaire. - Patients with pelvic inflammatory disease, urinary tract or vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy. - Patients who are breast feeding or have breastfed the last 6 months prior to Baseline Visit. - Patients who are pregnant or have been pregnant within the last 12 months. - Treatment with SSRIs. - Treatment with systemic glucocorticoids. - Treatment with sex steroid hormones such as androgens, estrogens other than in low dose combined ET/P, or gestagens. - Treatment w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the PK profile of TBS-2 administered BID in patients with HSDD or SA.;Secondary Objective: To evaluate the initial PD efficacy of TBS-2 administered BID in patients with HSDD or SA. To evaluate the safety of intranasal TBS-2 BID versus Intrinsa® (patch) in patients with HSDD or placebo in patients with SA. ;Primary end point(s): a) To evaluate the PK profile of TBS-2 administered BID in patients with HSDD or SA The serum concentrations of total testosterone and dihydrotestosterone will be measured using validated LC/MS/MS. The following pharmacokinetic parameters will be determined for all subjects: - Cmin, Cmax, tmax, PTF and PTS will be determined, for each dosing interval. - AUC0-t, and Cavg, will be calculated for each dosing interval. - The percentage of time within, below, and above the physiological reference range for serum testosterone and dihydrotestosterone | — |
Countries
Netherlands
Outcome results
None listed