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

NCT ID: NCT00620035

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-10-31

Brief Summary

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.

Conditions

Contraception

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Radiopaque Etonogestrel Implant

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.

Group Type: EXPERIMENTAL

Radiopaque Etonogestrel Implant

Intervention Type: DRUG

One implant inserted for a 3-year treatment period

Interventions

Radiopaque Etonogestrel Implant

One implant inserted for a 3-year treatment period

Intervention Type: DRUG

Other Intervention Names

SCH 900415

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.

Reference Type: DERIVED

PMID: 22939402 (View on PubMed)

Other Identifiers

34530

Identifier Type: -

Identifier Source: secondary_id

P05702

Identifier Type: -

Identifier Source: org_study_id