Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01364623
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2011-05-27
Brief Title:
PK Study of Testosterone Nasal Gel TBS-2 in Healthy Premenopausal Women
Sponsor:
Acerus Pharmaceuticals Corporation
Organization:
Acerus Pharmaceuticals Corporation
Study Overview
Official Title:
An Open-label Single and Multiple Application of Intranasal Testosterone Gel TBS-2 in Healthy Premenopausal Female Subjects at Three Dose Levels
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was 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 was also conducted
In addition assessing the bioavailability of free testosterone dihydrotestosterone SHBG and estradiol through pharmacokinetic profiles was also conducted
Detailed Description:
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
Period I
Subjects were 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 remained institutionalized until Day 4 morning and were checked out after the 48 hour blood draw and study close-out for those that did not continue with Period II
Period II Multi-Dose
At the end of Period 1 a total of 8 subjects sampled from these 3 cohorts who were willing and able to continue with the multiple-dose portion of the study were selected to participate in Period 2 Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3 and were checked out after the 48 hour blood draw and study close-out
Period I
Subjects were 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 remained institutionalized until Day 4 morning and were checked out after the 48 hour blood draw and study close-out for those that did not continue with Period II
Period II Multi-Dose
At the end of Period 1 a total of 8 subjects sampled from these 3 cohorts who were willing and able to continue with the multiple-dose portion of the study were selected to participate in Period 2 Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3 and were checked out after the 48 hour blood draw and study close-out
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None