Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism

What Was Tested

The trial (not phased) is built around ACTH (Corticotropin) and CRH (Corticotropin-Releasing Hormone).

In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected.

This is at least true for those with a complete insufficiency of the anterior pituitary.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Patients with hypopituitarism Cross over design: see interventions 1-2.

Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism.

The registry classes the interventions as other.

Who Took Part

Enrollment: 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18-75 years. Complete insufficiency of the anterior pituitary. Stable hormone substitution for at least 3 months.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: hormone excess in the past; sleep disorder, e.g. sleep apnea syndrome; age 18-75 years.

How the Study Was Run

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

Because people in this ACTH (Corticotropin) 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 ACTH (Corticotropin) and the comparison at some point, usually with a gap in between.

In this single-blind ACTH (Corticotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2008-02 with completion listed for 2008-10.

It ran at 1 site in Germany.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Sleep-EEG variables, conventionally and quantitatively analyzed (time frame: within the first month).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of ACTH (Corticotropin) and CRH (Corticotropin-Releasing Hormone) in 30 people.

Its size is small, so on its own it can only give an early look.

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

More context: the ACTH (Corticotropin) compound page and the CRH (Corticotropin-Releasing Hormone) compound page, all human trials.