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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23980
Enrollment
20
Registered
2005-09-18
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy female volunteers from 18-45 years.

Exclusion criteria

Exclusion criteria: 1. Underage; 2. Contra-indication for use of the contraceptive ring, skin patch or oral contraceptives, as termed by WHO, NVOG and 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. Chronical or acute diseases; 7. Lupus anticoagulans.

Design outcomes

Primary

MeasureTime frame
APC-resistance.

Secondary

MeasureTime frame
Other coagulation factors.

Contacts

Public ContactBea Hiemstra

Leiden University Medical Center (LUMC), Department of Gynaecology, P.O. Box 9600

B.Hiemstra@lumc.nl+31 (0)71 5262871

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)