Status:
COMPLETED
A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)
Lead Sponsor:
Organon and Co
Conditions:
Contraception
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation...
Eligibility Criteria
Inclusion
- Woman of 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 \<= 35 kg/m\^2;
- 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 Radiopaque Implant.
- 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 Radiopaque Implant 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 Radiopaque Implant
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00620035
Start Date
March 1 2007
End Date
October 1 2010
Last Update
February 4 2022
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