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

NCT ID: NCT00620464

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-02-28

Brief Summary

The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Radiopaque Implanon (ro imp)

The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.

Group Type: ACTIVE_COMPARATOR

Radiopaque Implanon

Intervention Type: DRUG

Radiopaque rod for 3 years

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.

Group Type: ACTIVE_COMPARATOR

Implanon (etonogestrel implant)

Intervention Type: DRUG

Implanon (etonogestrel implant) for 3 years

Interventions

Radiopaque Implanon

Radiopaque rod for 3 years

Intervention Type: DRUG

Implanon (etonogestrel implant)

Implanon (etonogestrel implant) for 3 years

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Schnabel P, Merki-Feld GS, Malvy A, Duijkers I, Mommers E, van den Heuvel MW. Bioequivalence and x-ray visibility of a radiopaque etonogestrel implant versus a non-radiopaque implant: a 3-year, randomized, double-blind study. Clin Drug Investig. 2012 Jun 1;32(6):413-22. doi: 10.2165/11631930-000000000-00000.

Reference Type: DERIVED

PMID: 22540269 (View on PubMed)

Other Identifiers

34528

Identifier Type: -

Identifier Source: secondary_id

P05720

Identifier Type: -

Identifier Source: org_study_id