A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(COMPLETED)(P05720) - Full Text View

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00620464

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 III

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

Drug Information available for: Etonogestrel

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

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

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 - French Health Products Safety Agency; 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 February 12, 2012