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NCT01686828 · ClinicalTrials.gov registry record · Phase 1
T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin
A Phase 1 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT01686828: Completed Phase 1 study, sponsored by University of Washington.
NCT01686828 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01686828, a Phase 1 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
Primary Outcome
Whole body insulin sensitivity as quantified by Matsuda Index at the end of the treatment period, calculated by the following equation: 10,000/square root of(FPG\*FI)\*(FPG+PG30\*2+PG60\*2+PG90\*2+PG120)/8\*(FPI+PI30\*2+PI60\*2+PI90\*2+PI)/8). FPG=fasting plasma glucose level; FPI=fasting plasma insulin level; PG30,60,90, and 120=plasma glucose levels sampled at 30,60,90, and 120 minutes after oral glucose load; PI30,60,90, and 120=plasma insulin levels sampled at 30,60,90, and 120 minutes after
Interventions
- DRUG Letrozole
- DRUG Acyline
- DRUG Testosterone 1.62% gel
- DRUG Placebo gel (for Testosterone 1.62% gel)
- DRUG Placebo pill (for Letrozole)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2013-06 |
| Est. Completion | 2017-12 |
| Phase | Phase 1 |
What the finished NCT01686828 record still lists
NCT01686828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT01686828 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01686828 about?
NCT01686828 is a clinical study titled "T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin". The purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.
What is the current status of trial NCT01686828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2013-06. Estimated completion is 2017-12.
What interventions are being tested in trial NCT01686828?
The interventions under investigation include: Letrozole (DRUG), Acyline (DRUG), Testosterone 1.62% gel (DRUG), Placebo gel (for Testosterone 1.62% gel) (DRUG), Placebo pill (for Letrozole) (DRUG).
Who is sponsoring clinical trial NCT01686828?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01686828's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 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
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