Contraception
Conditions
Brief summary
This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception. The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.
Interventions
DRUGEtonogestrel-releasing IUS
Low dose; treatment duration of 6 months with a possible extension to 12 months
DEVICEMultiload-cu 375®
Duration of 6 months with a possible extension to 12 months
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female subjects in need for contraception will be selected to participate in the trial; * Each subject must be \>=18 to \<=40 years of age at screening and in need for contraception; * Each subject must have given birth to at least one child (gestational age \>=28 weeks); * Each subject must have a uterus with a measured length between 6.0 and 9.0 cm (extremes included) from external os to fundus uteri.
Exclusion criteria
* A subject must not be pregnant or suspected to be pregnant; * A subject must not have had an ectopic pregnancy in the past or must not have a history or presence of predisposing factors for this condition such as salpingitis, endometritis or pelvic peritonitis; * A subject must not have a history or presence of any malignancy; * A subject must not have a history or presence of premalignant disease of the uterus or cervix, including endometrial hyperplasia, or (other) sex-steroid sensitive premalignancies; * A subject must not have an active venous thromboembolic disorder (e.g. deep vein thrombosis, pulmonary embolism); * A subject must not have a history or presence of severe hepatic disease with AST and/or ALT levels of \>=3 times the upper normal limit; * A subject must not have congenital or acquired malformations or distortions of the uterus or cervix; * A subject must not have large or multiple uterine fibromyomata, or a smaller uterine fibromyoma which may interfere with the insertion of the MIUS/IUD according to the investigator; * A subject must not have vaginal bleeding of undiagnosed etiology; * A subject must not have dysmenorrhea interfering with daily activities or menorrhagia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome for the trial is insertion and removal characteristics, adverse event reporting and subject's satisfaction with the ENG-MIUS | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal bleeding pattern | Days 92 to 182 |
Countries
Germany
Outcome results
None listed