Comparative Bioavailability and Bioequivalence of Testosterone Transdermal Gel Versus Testogel® Dosiergel 16.2 mg/g gel: A Single-Dose, Open-Label, Randomized, Full Replicate, Four-Period Crossover Study in Healthy Female Subjects Under Fasting Conditions.
interventional
N/A
1 country
1
To compare the bioavailability between Test and Reference products.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2022
Actual (reported)Cmax and AUC0-t estimated from baseline corrected testosterone will be the primary pharmacokinetic parameters, AUC0-∞ will be the secondary pharmacokinetic parameter.
Safety assessments will include physical examination, detailed skin examination, vital signs, 12-lead ECG, clinical laboratory tests, skin irritation/tolerability assessments and adverse events (AEs) monitoring.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Testogel Dosiergel 16,2 mg/g Gel
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
GEL
View registry recordFormulated product
Testosterone 1.62%; transdermal gel metered-dose pump
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TRANSDERMAL GEL
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Testogel Dosiergel 16,2 mg/g Gel
Named ingredient: Testosterone
View registry recordTestosterone 1.62%; transdermal gel metered-dose pump
Named ingredient: Testosterone
View registry recordBlueclinical Investigacao E Desenvolvimento Em Saude Lda.
Porto, 4250-449, Portugal
Jorge Avilés
First Submitted
October 20, 2022
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Safety and Efficacy Trial of Testosterone Undecanoate
Contact the study team to confirm eligibility.