MEN-Study: A randomized cross-over study on the effects of the skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive on the anticoagulations pathways
| ISRCTN | ISRCTN54277211 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54277211 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 19/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bea Hiemstra
Scientific
Scientific
Leiden University Medical Center Department of Gynaecology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5262871 |
|---|---|
| B.Hiemstra@lumc.nl |
Study information
| Study design | Randomised open label active controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Scientific title | |
| Study acronym | MEN-Study (Microgynon 30-EVRA-Nuvaring Study) |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Femal contraception, healthy person |
| Intervention | Skin patch and the vaginal ring versus a levonorgestrel containing oral contraceptive |
| Intervention type | Other |
| Primary outcome measure | APC-resistance |
| Secondary outcome measures | Other coagulation factors |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target number of participants | 20 |
| Key inclusion criteria | Healthy female volunteers from 18-45 years |
| Key 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 |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center Department of Gynaecology
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Gynaecology
P.O. Box 9600
Leiden
2300 RC
Netherlands
"ROR" |
https://ror.org/027bh9e22 |
|---|
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC), Department of Gynaecology (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2009 | Yes | No |
