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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620464
• Other study ID #: P05720
• Secondary ID: 34528
• Status: Completed
• Phase: Phase 3
• Start date: May 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Radiopaque Implanon
Radiopaque rod for 3 years
• Implanon (etonogestrel implant)
Implanon (etonogestrel implant) for 3 years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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