Estradiol-Receptor Blockade in Older Men and Women

What Was Tested

The trial (phase 1) is built around Ghrelin and GHRH (Growth Hormone-Releasing Hormone).

Repletion of testosterone (Te) in older men drives GH secretion after its aromatization to estradiol (E2), which acts via the estrogen receptor (ER).

Conversely, the researchers postulate that estrogen deprivation in postmenopausal women attenuates growth hormone (GH) secretion and insulin-like growth factor-1 (IGF-I) production, thus favoring development of metabolic syndrome in men treated with toremifene, a new estrogen antagonist used adjunctively in prostatic cancer.

It had two arms (groups): Oral Toremifene/Oral Placebo (experimental) and Oral Placebo/Oral Toremifene (experimental).

The registry classes the interventions as drug.

More on the Plan

Systemic concentrations of Te, E2, GH, IGF-I and insulin growth factor binding protein 3 (IGFBP-3) decline in healthy aging men and women.

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 alone stimulates GH secretion in young and older women.

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

Who Took Part

40 actual participants took part.

It was open to people of any sex aged from 50 years up to 80 years.

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

Examples of who could join: BMI 18-35 kg/m2. Community dwelling; and voluntarily consenting. Recent use of psychotropic or neuroactive drugs (within five biological half-live);. Obesity (outside weight range above);. Drug or alcohol abuse, psychosis, depression, mania or severe anxiety;.

The full record lists 18 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

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

In the crossover set-up each of the participants took both Ghrelin and the comparison in turn, acting as their own control.

As a double-blind Ghrelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2014-12 with completion listed for 2016-05.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Summed mass of growth hormone over 10 hours.

It also tracked 1 secondary outcome, for example Growth hormone responsiveness over last 2h.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Ghrelin and GHRH (Growth Hormone-Releasing Hormone) in 40 people.

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

More context: the Ghrelin compound page and the GHRH (Growth Hormone-Releasing Hormone) compound page, all human trials.