Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT01295294
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent
* Healthy female subjects requesting contraception
* Age: 18 - 45 years inclusive
* Successful interval insertion of MIRENA
* History of regular cyclic menstrual periods
* Normal or clinically insignificant cervical smear not requiring further follow up
Exclusion Criteria:
* Pregnancy or lactation
* Climacteric symptoms prior to the screening visit
* Known or suspected clinically significant ovarian cysts, endometrial polyps, fibroids, or other genital organ pathology, that, in the opinion of the investigator, may interfere with the assessment of the bleeding profile during the study
* Undiagnosed abnormal genital bleeding
* Current or history of thrombembolic disease, or established risk factors for venous thromboembolism
* Current migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, or exceptionally severe headaches
* Hypersensitivity to any ingredient of the investigational medicinal products or the non-investigational medicinal product
* Daily or frequent use of a nonsteroidal anti-inflammatory drug (NSAIDs) for any condition
* Not willing to use nonsteroidal anti-inflammatory drug (NSAIDs) medication as pain medication during the double blind treatment period
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01295294
Study Brief:
Protocol Section:
NCT01295294