Status:
COMPLETED
Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
Lead Sponsor:
University of Sao Paulo
Conditions:
Breastfeeding
Contraception
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.
Detailed Description
Many contraceptive methods are currently available. However, about 50% of all pregnancies in the world are not planned, most of them occurring in developing countries. Long-lasting reversible contrace...
Eligibility Criteria
Inclusion
- age between 18 and 35 years
- Postpartum contraception desire
Exclusion
- smoking, alcoholism or drug addiction
- presence of systemic diseases (diabetis melittus, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia)
- having a body mass index ≥ 30 kg/m2
- personal history of arterial or venous thrombosis
- using any medication that might interfere with blood coagulation or with the assessment of haemostatic and inflammatory variables
- presenting alterations in hepatic enzymes
- being allergic to local anaesthetics (xylocaine)
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00828542
Start Date
July 1 2007
End Date
February 1 2008
Last Update
May 15 2017
Active Locations (1)
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1
University of Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900