Research with human participants

Overview of medical research in the Netherlands

Levonorgestrel spiraal versus progesteron oraal voor de behandeling van hyperplasie zonder atypie van het endometrium.

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Last updated:

Treatment of endometrial hyperplasia by an IUD that contains progesteron is more effective and has less side-effects than the treatment with progesteron oral.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Reproductive neoplasms female benign
Study type
Interventional

ID

NL-OMON36959

Source

ToetsingOnline

Brief title

HYPROLEV-study

Condition

  • Reproductive neoplasms female benign

Synonym

abnormal endometrial tissue, precancer leasion of woomb

Research involving

Human

Sponsors and support

Primary sponsor :
obstetrie en gynaecologie
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
endometrium, hyperplasia, levonorgestrel IUD, progesteron

Outcome measures

Primary outcome

endometrial atrofy after treatment

Secondary outcome

less side-effects in the study-group than the control-group

Background summary

Endometrial hyperplasia without atypie is treated by oral progestron. This
treatment has some side-effects. Another way of treating this condiion is by an
IUD that contains progesteron. This method is already been investigated and is
also effective. We think that this second option (the IUD which contains
progesteron) is more effective and is also has less side-effects than the oral
treatment. That is why we want to do this ranomized controlled trial. For this
study we need to include 90 patients.

Study objective

Treatment of endometrial hyperplasia by an IUD that contains progesteron is
more effective and has less side-effects than the treatment with progesteron
oral.

Study design

prospective randomized clinical trial

Intervention

One group will be treated bij oral progesteron and the oter group will get a
levonorgestrel-IUD.

Study burden and risks

Patients are four times asked to fill in a form which will take about 10-15
minutes each time.

There are no risks for the patient in this study.

Public
Selecteer

Debyelaan 25
6202 AZ Maastricht
Nederland
Scientific
Selecteer

Debyelaan 25
6202 AZ Maastricht
Nederland

Listed location countries

Netherlands

Age

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

Inclusion criteria

endometrial hyperplasia (simple and complex), Dutch language

Exclusion criteria

endometrial cancer, hyperplasia with atypie, history of hyperplasia, contra-indication for treatment with progesteron, biopt not possible for any reason

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
90
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Mirena
Generic name :
Levonorgestrel IUD
Registration
:
Yes - NL outside intended use
Product type :
Medicine
Brand name :
provera
Generic name :
medroxyprogesteron
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)

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
EudraCT EUCTR2008-006715-21-NL
CCMO NL24978.068.08