Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01096329 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®
A Phase 1 study, sponsored by VIVUS.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01096329: Clinical Trial Phase 1 study, sponsored by VIVUS.
NCT01096329 is a Phase 1 study that was terminated before completion, run by VIVUS. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01096329, a Phase 1 study, was terminated before completion, sponsored by VIVUS.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.
Primary Outcome
The following PK parameters of testosterone will be measured AUC0-24, AUC0-48, AUC0-72, AUC0-96, Cavg, Cmin, Cmax
Interventions
- DRUG Testosterone Spray 5% and 1%
- DRUG Intrinsa® Patch and Testosterone Spray 5%
- DRUG Intrinsa® Patch and Testosterone Spray 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-02 |
| Phase | Phase 1 |
Why NCT01096329 stopped before completion
NCT01096329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Testosterone Spray 5% and 1% is the first listed.
NCT01096329 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01096329 about?
NCT01096329 is a clinical study titled "A Pharmacokinetic (PK) Study to Compare the Absorption of Two Formulations of Transdermal Testosterone Spray and Intrinsa®". The purpose of this study is to determine if the absorption of the testosterone spray is the same as the Intrinsa® Patch.
What is the current status of trial NCT01096329?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2010-02.
What interventions are being tested in trial NCT01096329?
The interventions under investigation include: Testosterone Spray 5% and 1% (DRUG), Intrinsa® Patch and Testosterone Spray 5% (DRUG), Intrinsa® Patch and Testosterone Spray 1% (DRUG).
Who is sponsoring clinical trial NCT01096329?
This trial is sponsored by VIVUS, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01096329's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia