A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00620464

Purpose

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON. As a secondary objective, the x-ray visibility of Radiopaque IMPLANON will be assessed.

Condition	Intervention	Phase
Contraception	Drug: Radiopaque Implanon Drug: Implanon (etonogestrel implant)	Phase III

MedlinePlus related topics: X-Rays

Drug Information available for: Etonogestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:	A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON

Further study details as provided by Organon:

Primary Outcome Measures:

Bioequivalence as determined by AUC and Cmax for ENG. [ Time Frame: 6 months, 24 months and 36 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of x-ray visibility by x-ray imaging. [ Time Frame: Just after rod insertion (<= 14 days), and just before rod removal (<= 14 days). ] [ Designated as safety issue: No ]
Contraceptive efficacy as determined by urine pregnancy test. [ Time Frame: At screening, just before implant insertion, at all visits from month 2 onwards, and at 36 months (or at time of implant removal if discontinuing early). ] [ Designated as safety issue: No ]
Drug safety as determined by [S]AE monitoring, physical and gynecological history/exams, vital signs, and inspection of implantation site. [ Time Frame: [S]AEs reported whenever they occur. Phys/gyn history/exams, and vital signs done at screening. Vital signs also done at each study visit (2 mos. onwards). Phys/gyn exams at 36 months. Inspection of implant site at 2 months and all subsequent visits. ] [ Designated as safety issue: Yes ]

Enrollment:	108
Study Start Date:	May 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Active Comparator Radiopaque Implanon	Drug: Radiopaque Implanon Radiopaque rod for 3 years
Arm 2: Active Comparator Implanon (etonogestrel implant)	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

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	34528, P05720
Study First Received:	February 11, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00620464
Health Authority:	France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Desogestrel
3-keto-desogestrel

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009