Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-01-17 @ 9:37 PM
Study NCT ID:
NCT02667561
Status:
WITHDRAWN
Last Update Posted:
2018-06-06
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodinamic and Safety of Testosterone Gel 1%
Sponsor:
Biolab Sanus Farmaceutica
Organization:
Study Overview
Official Title:
Phase I Clinical Trial for Evaluation of Pharmacokinetics, Pharmacodynamics and Safety of Testosterone Gel 1% for Topical Use, After Administration of Three Different Doses (2.2 mg, 4.4 mg, 8.8 mg and Placebo) for 28 Consecutive Days in Post-menopausal Women.
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study has been cancelled and it has not been initiated.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, for 28 days
Detailed Description:
This is a Phase I, open-label, parallel trial to evaluate Pharmacokinetics, Pharmacodynamics and Safety of Testosterone gel 1% for topic usage in post-menopausal women, Study participants will receive investigational product for 28 consecutive days, once daily, as per the following allocation: 2.2 mg, 4.4 mg. 8.8 mg or placebo.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: