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

• ClinicalTrials.gov Identifier: NCT00620464
• Recruitment Status: Completed
• First Posted: February 21, 2008
• Results First Posted: May 17, 2010
• Last Update Posted: February 4, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Contraception	Drug: Radiopaque Implanon; Drug: Implanon (etonogestrel implant)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-Blind, Parallel Group, Bioequivalence Study of IMPLANON and Radiopaque IMPLANON
• Study Start Date: May 2005
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: February 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Bioequivalence of Implanon® and Radiopaque Implanon. [ Time Frame: 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).

2. Bioequivalence of Implanon® and Radiopaque Implanon [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00620464
• Other Study ID Numbers: P05720; 34528
• First Posted: February 21, 2008
• Results First Posted: May 17, 2010
• Last Update Posted: February 4, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

Etonogestrel; Desogestrel; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female; Contraceptives, Oral, Hormonal; Contraceptives, Oral; Contraceptives, Oral, Synthetic; Progestins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists