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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620464
First Posted: February 21, 2008
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

    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 ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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

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
First Submitted: February 11, 2008
First Posted: February 21, 2008
Results First Submitted: February 17, 2010
Results First Posted: May 17, 2010
Last Update Posted: August 13, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Etonogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists