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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00620464
First received: February 11, 2008
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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
Criteria

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
No Contacts or Locations Provided
  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