Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00620464
First received: February 11, 2008
Last updated: September 25, 2014
Last verified: September 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00620464     History of Changes
Other Study ID Numbers: P05720, 34528
Study First Received: February 11, 2008
Results First Received: February 17, 2010
Last Updated: September 25, 2014
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
Contraceptive Agents, Female
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014