Condition category
Pregnancy and Childbirth
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Bea Hiemstra

ORCID ID

Contact details

Leiden University Medical Center Department of Gynaecology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5262871
B.Hiemstra@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

MEN-Study (Microgynon 30-EVRA-Nuvaring Study)

Study hypothesis

The effect on Activated Protein C (APC)-resistance of the skin patch and the vaginal ring contraceptives, containing third generation gestagens, is significantly increased in comparison with oral contraceptives, containing second generation gestagens.

Ethics approval

Received from local medical ethics committee

Study design

Randomised open label active controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

Femal contraception, healthy person

Intervention

Skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

APC-resistance

Secondary outcome measures

Other coagulation factors

Overall trial start date

01/01/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy female volunteers from 18-45 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20

Participant exclusion criteria

1. Underage
2. Contra-indication for use of the contraceptive ring, skin patch or oral contraceptives, as termed by World Health Organization (WHO), Northen Virginia Oncology Group (NVOG) and the Dutch General Practitioners Society (Nederlands Huisartsen Genootschap [NHG])
3. Use of hormonal contraception or hormonal substitution therapy 2 months before inclusion
4. Pregnancy 3 months before inclusion or during the study
5. Use of medication with effect on the blood coagulation
6. Chronic or acute diseases
7. Lupus anticoagulans

Recruitment start date

01/01/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center Department of Gynaecology
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

Department of Gynaecology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Centre (LUMC), Department of Gynaecology (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18829069

Publication citations

  1. Results

    Fleischer K, van Vliet HA, Rosendaal FR, Rosing J, Tchaikovski S, Helmerhorst FM, Effects of the contraceptive patch, the vaginal ring and an oral contraceptive on APC resistance and SHBG: a cross-over study., Thromb. Res., 2009, 123, 3, 429-435, doi: 10.1016/j.thromres.2008.04.022.

Additional files

Editorial Notes