A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(COMPLETED)(P05720)
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Purpose
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
| Condition | Intervention | Phase |
|---|---|---|
|
Contraception |
Drug: Radiopaque Implanon Drug: Implanon (etonogestrel implant) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON |
- Bioequivalence of Implanon® and Radiopaque Implanon. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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).
- Bioequivalence of Implanon® and Radiopaque Implanon [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.
| Enrollment: | 108 |
| Study Start Date: | May 2005 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Radiopaque Implanon (ro imp)
The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
|
Drug: Radiopaque Implanon
Radiopaque rod for 3 years
|
|
Active Comparator: Implanon (imp)
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)
Implanon (etonogestrel implant) for 3 years
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided by Schering-Plough
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00620464 History of Changes |
| Other Study ID Numbers: | 34528, P05720 |
| Study First Received: | February 11, 2008 |
| Results First Received: | February 17, 2010 |
| Last Updated: | September 23, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
3-keto-desogestrel Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013