Research with human participants

Overview of medical research in the Netherlands

A double-blind, randomized study to evaluate plasma prolactin levels in healthy volunteers after single oral doses of lorazepam

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Evaluation of the effect of single oral doses of lorazepam on plasma concentration of prolactin

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Hypothalamus and pituitary gland disorders
Study type
Interventional

ID

NL-OMON37691

Source

ToetsingOnline

Brief title

Prolactin levels after single oral doses of lorazepam

Condition

  • Hypothalamus and pituitary gland disorders
  • Sleep disturbances (incl subtypes)

Synonym

hyperprolactinemia, increased prolactin levels

Research involving

Human

Sponsors and support

Primary sponsor :
Centre for Human Drug Research
Source(s) of monetary or material Support :
Centre for Human Drug Research

Intervention

Keyword :
healthy volunteer, lorazepam, prolactin

Outcome measures

Primary outcome

Plasma prolactin concentration

Secondary outcome

not applicable

Background summary

A stimulating effect of lorazepam and other GABA agonists on plasma prolactin
levels are known from animal studies. In healthy volunteers, this effect has
not been confirme. However, these studies suffered from small sample sizes. The
present study aims to evaluate prolactin levels after administration of
lorazepam or placebo in a larger population of healthy volunteers.

Study objective

Evaluation of the effect of single oral doses of lorazepam on plasma
concentration of prolactin

Study design

Dubbel-blind, randomized and placebo-controlled, cross-over study with
bloodsamples of healthy volunteers (n = 32) obtained in two other studies, in
which the volunteers were administered single oral doses of 2 mg lorazepam or
placebo.

These two studies are:
ClinicalTrials.gov identifier NCT00720421; EudraCT 2008-001756-51
ClinicalTrials.gov identifier NCT00720421; EudraCT 2008-001757-17

Intervention

not applicable

Study burden and risks

not applicable

Public
Centre for Human Drug Research

Zernikedreef 10
2333 CL Leiden
NL
Scientific
Centre for Human Drug Research

Zernikedreef 10
2333 CL Leiden
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Not applicable. This study will consist of performing additional analysis of prolactin concentration in blood samples obtained from healthy volunteers in two other (separate) studies. Signed informed consent forms from all volunteers are available and cover this additional analysis. As a result, no new volunteers will be included

Exclusion criteria

Not applicable. This study will consist of performing additional analysis of prolactin concentration in blood samples obtained from healthy volunteers in two other (separate) studies. Signed informed consent forms from all volunteers are available and cover this additional analysis. As a result, no new volunteers will be included

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Double blinded (masking used)
Control :
Placebo
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
32
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Leiden-Den Haag-Delft (Leiden)

metc-ldd@lumc.nl

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL40111.058.12