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

Organon

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Implanon (etonogestrel implant); Drug: Radiopaque Implanon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620464

34528

P05720

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups

Radiopaque Implanon (ro imp)

Active Comparator group

Description:

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

Treatment:

Drug: Radiopaque Implanon

Implanon (imp)

Active Comparator group

Description:

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.

Treatment:

Drug: Implanon (etonogestrel implant)