Impact of Estradiol Addback

What Was Tested

This registered phase 1 trial tested Degarelix.

Repletion of testosterone (T) in older men drives Growth Hormone secretion after its aromatization to estradiol (E2) by potentiating endogenous GH drive.

It had four arms (groups): Degarelix/Te/placebo/ placebo (experimental), degarelix/Te/anastrozole/ placebo (experimental), degarelix/Te/ anastrozole/E2 patch (experimental) and degarelix/ placebo/placebo/no patch (experimental).

The registry classes the interventions as drug.

More on the Plan

Systemic concentrations of Te, E2, GH, Insulin-like Growth Factor-I and IGFBP-3 decline in healthy aging men.

Relative sex-steroid deprivation accentuates GH and IGF-I depletion, since Te stimulates GH and IGF-I production in older men, hypogonadal males of all ages, and patients undergoing (genotypic female-to-male) gender reassignment.

E2 per se stimulates GH secretion in women.

Because Te is converted to E2 by aromatization in the body, the researchers postulate that E2 is the active moiety in men also.

Who Took Part

43 actual participants took part.

It was open to men only aged from 60 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 60 healthy men (ages 60 to 80 y);. BMI 18-30 kg/m2. Community dwelling; and voluntarily consenting. Recent use of psychotropic or neuroactive drugs (within five biological half-live);. Obesity (outside weight range above);.

The full record lists 21 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Degarelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Degarelix and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Degarelix.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2013-05 with completion listed for 2016-09-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): BioStatistical Analysis (time frame: Subjects will undergo 15-h overnight (2200 - 1300 h) fasting, 10-min blood sampling).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Degarelix in 43 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Degarelix compound page, all human trials.