Phase 2 Completed N=53 Randomized Double-blind Treatment

T-IR- Study to Understand the Effects of Testosterone and Estrogen on the Body's Response to the Hormone Insulin

Insulin Resistance · Type 2 Diabetes Mellitus · Obesity · Androgen Deficiency

Source: ClinicalTrials.gov NCT01686828 ↗

Enrolled (actual)

Serious AEs

5.7%

Results posted

Jun 2017

Primary outcomePrimary: Insulin Sensitivity Quantified by Matsuda Index — 5.0; 9.4; 7.2; 7.3 units on a scale — p=0.164

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Insulin Sensitivity Quantified by Matsuda Index	5.0; 9.4; 7.2; 7.3	0.164
SECONDARY Changes in Body Composition	1.1; 0.7; -0.4; 0.5; -1.2; -1.4	0.003 sig
SECONDARY Changes in Adipose Tissue Gene Expression	7493; 8224; 7885; 8320	>0.1

Eligibility Criteria

Inclusion Criteria

Prostate-specific antigen (PSA) ≤ 3 ng/mL
Age 25-55 years
Ability to understand the study, study procedures and provide informed consent
Serum total T > 300 ng/dL
Normal reproductive history and exam
International Prostate Symptom Score (IPSS) 50 or 280 lbs. or BMI ≥ 33
Desire for fertility in the next 6 months or current pregnant partner
Sperm concentration 160/100 mmHg); subjects with well-controlled BP on medical therapy will be eligible to participate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01686828). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.