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

A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON

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

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Drug: Radiopaque Implanon; Drug: Implanon (etonogestrel implant)

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioequivalence of Implanon® and Radiopaque Implanon.	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).	3 years
Bioequivalence of Implanon® and Radiopaque Implanon	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.	3 years

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: February 11, 2008
• First Submitted That Met QC Criteria: February 11, 2008
• First Posted (Estimate): February 21, 2008

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Desogestrel; Etonogestrel
• Other Study ID Numbers: P05720; 34528