A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)

Study Overview
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Brief Summary
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The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

Official Title
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A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON

Conditions
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Contraception

Intervention / Treatment
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* Drug: Radiopaque Implanon
* Drug: Implanon (etonogestrel implant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiopaque Implanon (ro imp)<br>The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate. | Drug: Radiopaque Implanon<br>* Radiopaque rod for 3 years<br>|
| Active Comparator: Implanon (imp)<br>Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane. The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year. | Drug: Implanon (etonogestrel implant)<br>* Implanon (etonogestrel implant) for 3 years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence of Implanon® and Radiopaque Implanon. | Bioequivalence testing was performed based on serum etonogestrel AUC0-6months, AUC0-24months, and AUC0-36months. Bioequivalence was to be concluded when the 90% confidence limits of AUC0-6months, AUC0-24months, and AUC0-36months were fully contained within the acceptance range of 0.80-1.25. AUC0-6months (Area under the curve from zero to six months). AUC0-24months (Area under the curve from zero to 24 months). AUC0-36months (Area under the curve from zero to 36 months). | 3 years | 
| Bioequivalence of Implanon® and Radiopaque Implanon | Bioequivalence testing was performed based on serum etonogestrel Cmax. Bioequivalence was to be concluded when the 90% confidence limits of Cmax were fully contained within the acceptance range of 0.80-1.25. Cmax (pg/mL): Peak concentration. | 3 years |