Primary and secondary hypogonadism MedDRA version: 20.0 Level: PT Classification code 10052649 Term: Primary hypogonadism System Organ Class: 10014698 - Endocrine disorders MedDRA version: 20.0 Level: PT Classification code 10059594 Term: Secondary hypogonadism System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Natesto®
Product Name: Natesto™/TBS-1
Pharmaceutical Form: Nasal gel
INN or Proposed INN: TESTOSTERONE
CAS Number: 58-22-0
Current Sponsor code: Testosterone
Other descriptive name: 17ß-Hy
Sponsors
Acerus Biopharma Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ARM 1 (naïve patients): Participants who meet all of the following inclusion criteria will be eligible for participation in the study: 1. Hypogonadal boys 2. Chronological age 12 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ARM 1 (naïve patients) AND ARM 2 (non-naïve patients): Participants who meet any of the following criteria will be excluded from participation in the study: 1. Any active allergic condition or presentation of symptoms including allergic rhinitis; 2. An upper respiratory tract infection; 3. Use of any form of intranasal medication delivery other than periodic short-term (less than 3 days) use of sympathomimetic decongestants, within the last 3 months; 4. In the opinion of the Investigator, significant intercurrent disease of any type, in particular liver, kidney, heart disease, stroke, or psychiatric illness; 5. Any active malignancy, however a prior history of a malignancy which has been in remission for 12 months will be allowed; 6. History of nasal disorders, nasal or sinus surgery, nasal fracture within the previous 6 months or nasal fracture that caused a deviated anterior nasal septum surgery, mucosal inflammatory disorders, specifically Sjogren’s syndrome; 7. History of severe adverse drug reactions to testosterone therapies; 8. Current treatment with other androgens (e.g., dehydroepiandrosterone [DHEA]), anabolic steroids, or other sex hormones; 9. Treatment with drugs that interfere with the metabolism of testosterone, such as anastrozole, clomiphene, dutasteride, finasteride, flutamide, ketoconazole, spironolactone, or testolactone; 10. Diabetes mellitus; 11. Participation in any other research study during the conduct of this study or 30 days prior to the initiation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the PK profile of serum testosterone, serum dihydrotestosterone and serum estradiol [AUC, Cavg, Cmin, Cmax, and tmax] after treatment with variable doses of Testosterone Nasal Gel 4.5% w/w (NATESTO™);Secondary Objective: To evaluate the following: • Safety monitoring; • Acceptability of gel will be assessed using questionnaires to determine: o Tolerability o Ease of administration o Patient preference (for non-naïve patients) o Investigator assessment of use of nasal gel product o Assessment of dose delivery/deposition relative to paediatric nasal anatomy;Primary end point(s): Pharmacokinetic parameters for total serum testosterone, serum dihydrotestosterone and serum estradiol including AUC, Cavg, Cmin, Cmax and Tmax, using 9 samples per participant taken predose and up to 12 hours post each dose.;Timepoint(s) of evaluation of this end point: Data from blood draws at the following time points will be used to calculate the PK parameters listed as the primary end points: • Naïve patients: 0, 20 min, 40 min, 60 min (±2 min), 90 min, 2 h, 4 h, 8 h, 12 h (±5 min) on both Day 1 and Day 2. • Non-naïve patients: 0, 20 min, 40 min, 60 min (±2 min), 90 min, 2 h, 4 h, 8 h, 12 h (±5 min) on Day 1 and 0, 20 min, 40 min, 60 min (±2 min), 90 min, 2 h, 4 h, 8 h, 12 h (±5 min) after both doses on Day 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Safety and tolerability assessments • Acceptability assessments ;Timepoint(s) of evaluation of this end point: Evaluated up to 36 hours for naïve patients and 48 hours for non naïve patients. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Affairs
Acerus Biopharma Inc.
Outcome results
None listed