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 measure
APC-resistance
Secondary outcome measures
Other coagulation factors
Overall trial start date
01/01/2005
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18829069
Publication citations
-
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.