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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT01434160
Eligibility Criteria:
Inclusion Criteria:
* The subject has signed and dated the informed consent form (ICF)
* The subject is female, generally healthy, post-menarcheal, nulliparous or parous, requiring contraception, and is under 18 years of age at the Screening visit
* The subject has regular menstrual cycles without hormonal contraceptive use (at regular intervals of 21-35 days)
* In the opinion of the investigator, the subject has general and uterine conditions suitable for the insertion of levonorgestrel intrauterine contraceptive system (LCS12) (uterine sound depth 6-10 cm)
* Has clinically normal safety laboratory results
* The subject has a normal or clinically insignificant cervical smear (i.e. one that does not require further follow up according to Bethesda or a comparable system)
* The subject is willing and able to attend the scheduled study visits and to comply with the study procedures
Exclusion Criteria:
* Known or suspected pregnancy or is lactating
* Vaginal delivery, cesarean delivery, or abortion less than 6 weeks before Visit 1
* History of ectopic pregnancies
* Infected abortion or postpartum endometritis less than 3 months before Visit 1
* Abnormal uterine bleeding of unknown origin
* Any lower genital tract infection (until successfully treated)
* Acute or history of recurrent pelvic inflammatory disease
* Congenital or acquired uterine anomaly
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT01434160
Study Brief:
Protocol Section:
NCT01434160