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NCT01323140 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems
A Phase 2 study of Hypogonadism, sponsored by Watson Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT01323140: Completed Phase 2 study of Hypogonadism, sponsored by Watson Pharmaceuticals.
NCT01323140 is a Phase 2 study of Hypogonadism that has completed, run by Watson Pharmaceuticals. The registered enrollment target is 40 participants, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01323140, a Phase 2 study of Hypogonadism, has completed, sponsored by Watson Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
Primary Outcome
Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (\>= 300 ng/dL to \<= 1030 ng/dL), at least 85% of subjects with Cmax \<= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax \>= 2500 ng/dL.
Conditions Studied
Interventions
- DRUG testosterone matrix transdermal system
Study Locations (2)
Florida
- Watson Investigational Site - Fort Meyers
Washington
- Watson Investigational Site - Tacoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT01323140 record still lists
NCT01323140 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 118-participant average among 21 other Hypogonadism trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Hypogonadism appearing as the primary indexed condition, and to 1 intervention - of which testosterone matrix transdermal system is the first listed.
NCT01323140 reports a single indexed study location in Florida, Washington.
Frequently Asked Questions
What is clinical trial NCT01323140 about?
NCT01323140 is a clinical study titled "Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems". Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
What is the current status of trial NCT01323140?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-04. Estimated completion is 2011-07.
What conditions does trial NCT01323140 study?
This clinical trial studies the following conditions: Hypogonadism.
What interventions are being tested in trial NCT01323140?
The interventions under investigation include: testosterone matrix transdermal system (DRUG).
Who is sponsoring clinical trial NCT01323140?
This trial is sponsored by Watson Pharmaceuticals, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01323140 being conducted?
This trial has 2 study locations across Florida, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hypogonadism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01323140's enrollment target sits among peer trials
40 14th of 21 higher than 7 of 21 other Hypogonadism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypogonadism 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
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