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

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Implanon (etonogestrel implant); Drug: Radiopaque Implanon

• Registration Number: NCT00620464
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Results First Submitted: 2010-02-17
• Results First Submitted QC: 2010-04-28
• Results First Posted: 2010-05-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implanon (imp)	Implanon (etonogestrel implant)	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.
Radiopaque Implanon (ro imp)	Radiopaque Implanon	The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.

Primary Outcome Measures

Name	Time	Method
Bioequivalence of Implanon® and Radiopaque Implanon	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.
Bioequivalence of Implanon® and Radiopaque Implanon.	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).