Status:
COMPLETED
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
Lead Sponsor:
Organon and Co
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
Eligibility Criteria
Inclusion
- At least 18 but not older than 40 years of age at the time of screening
- Good physical and mental health
- Regular cycles with a usual length between 24 and 35 days
- Body mass index ≥ 18 and ≤ 29
- Willing to give informed consent in writing
Exclusion
- Contraindications:
- known or suspected pregnancy
- active venous thromboembolic disorder (e.g. deep vein thrombosis,pulmonary embolism)
- presence or history of severe hepatic disease as long as liver function values have not returned to normal
- malignancy or pre-malignancy, if sex -steroid-influenced
- undiagnosed vaginal bleeding
- hypersensitivity to any of the components of Implanon/Radiopaque Implanon
- Hypertension, i.e. systolic blood pressure \>140 mmHg and/or diastolic blood pressure \> 90 mmHg.
- A history during pregnancy or during previous use of sex steroids of: jaundice and/or severe pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss
- Present use or use during 2 months prior to the start of Implanon/Radiopaque Implanon of one of the following drugs: phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, nelfinavir, griseofulvin or the herbal remedy St John's wort.
- Administration of investigational drugs within 2 months prior to the start of Implanon/Radiopaque Implanon
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00620464
Start Date
May 1 2005
End Date
February 1 2009
Last Update
February 4 2022
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