PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
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|ClinicalTrials.gov Identifier: NCT01364623|
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : June 5, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Female Sexual Dysfunction||Drug: Low dose testosterone nasal gel Drug: Medium dose testosterone nasal gel Drug: High dose testosterone nasal gel||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels|
|Study Start Date :||September 2011|
|Primary Completion Date :||January 2012|
|Study Completion Date :||February 2012|
|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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364623
|United States, Texas|
|Premier Research International LLC|
|Austin, Texas, United States, 78705|
|Study Director:||Natalia Tkachenko, MD||Trimel Pharmaceuticals Corporation|