A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)

Organon

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Radiopaque Etonogestrel Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620035

P05702

34530

Details and patient eligibility

About

The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess participant expectations and satisfaction with the Radiopaque Implant.

Enrollment: 301 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Woman of 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 <= 35 kg/m^2;
• 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 Radiopaque Implant.

  • 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 Radiopaque Implant 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 Radiopaque Implant

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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301 participants in 1 patient group

Radiopaque Etonogestrel Implant

Experimental group

Description:

Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA) The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray. The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.

Treatment:

Drug: Radiopaque Etonogestrel Implant