PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
The purpose of this study is to assess the bioavailability of total testosterone through pharmacokinetic profiles obtained following (a) single administration of three doses of TBS-2 b) multiple administration TBS-2.
In addition, assessing the bioavailability of free testosterone, dihydrotestosterone, SHBG and estradiol through pharmacokinetic profiles will also be conducted.
|Female Sexual Dysfunction||Drug: Low dose testosterone nasal gel Drug: Medium dose testosterone nasal gel Drug: High dose testosterone nasal gel||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels|
- Area under the plasma concentration curve (AUC) of testosterone following TBS-2 [ Time Frame: up to 3 days ]The following pharmacokinetic parameters will be calculated: Cmax, Tmax, AUC, half life
- Area under the plasma concentration versus time curve (AUC) of dihydrotestosterone and estradiol following TBS-2 [ Time Frame: up to 3 days ]The following pharmacokinetic parameters will be calculated: AUC, Cmax, Tmax, half life
- Number of subjects with adverse events [ Time Frame: Up to 5 days ]
- Vital Signs and Adverse Events: Blood Pressure, Body Temperature, Respiratory Rate, Heart Rate.
- Otorhinolaryngological examination with the nasal tolerance data presented in summary tables.
- Complete Blood Count: white blood count, hemoglobin and hematocrit.
- Clinical chemistry profile: Sodium, potassium, chloride, glucose, urea, creatinine, calcium, phosphate, uric acid, total bilirubin, albumin, AST, ALT, ALP, GGT, CK and cholesterol, hormone profiles.
|Study Start Date:||September 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: Low dose TBS-2||
Drug: Low dose testosterone nasal gel
Single dose administration
Other Name: TBS-2
|Experimental: Medium dose TBS-2||
Drug: Medium dose testosterone nasal gel
Single dose Administration
Other Name: TBS-2Drug: Medium dose testosterone nasal gel
multiple dose administration
Other Name: TBS-2
|Experimental: High dose TBS-2||
Drug: High dose testosterone nasal gel
single dose Administration
Other Name: TBS-2
This is a 2 Period study that requires overnight stays in clinic. Blood samples are required at all visits including sampling at predefined time periods during the overnight stays.
Subjects will be checked-in on Day 1 Period I to start their baseline testosterone measurement (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They will remain institutionalized until Day 4 morning, and will be checked out after the 48 hour blood draw and study close-out for those that do not continue with Period II.
Period II (Multi-Dose)
Subjects will be institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3, and will be checked out after the 48 hour blood draw and study close-out.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364623
|United States, Texas|
|Premier Research International LLC|
|Austin, Texas, United States, 78705|
|Study Director:||Natalia Tkachenko, MD||Trimel Pharmaceuticals Corporation|