Hormonal contraception in healthy women
Conditions
Interventions
Product Name: Radiopaque etonogestrel implant
Pharmaceutical Form: Implant
INN or Proposed INN: etonogestrel
CAS Number: 54048-10-1
Current Sponsor code: Org 3236
Other descriptive name: 3-keto-Desoge
Sponsors
NV Organon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Woman of at least (=)18 but not older than (=)40 years of age at the time of screening; 2. Good physical and mental health; 3. Regular cycles with a usual length between 24 and 35 days; 4. Body mass index =18 and =35 kg/m2; 5. Willing to give informed consent in writing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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. 2. Hypertension, i.e. systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg; 3. 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; 4. 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; 5. Administration of investigational drugs within 2 months prior to the start of Radiopaque Implant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant.;Secondary Objective: • to evaluate the removal of the Radiopaque Implant • to assess overall contraceptive efficacy and safety of the Radiopaque Implant • to assess X-ray visibility of the Radiopaque Implant • to assess subject’s expectations and satisfaction with the Radiopaque Implant ;Primary end point(s): User Satisfaction Questionnaire, Insertion and removal characteristics, other insertion and removal variables | — |
Countries
France, Germany, Sweden, United Kingdom
Outcome results
None listed