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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01684358
Eligibility Criteria:
Inclusion Criteria:
* Be willing to be randomized to receive the implant at the enrollment visit or in three months;
* Be 18-44 years of age;
* Not known to be HIV-positive;
* Have a negative pregnancy test at baseline;
* Not currently using an intrauterine device or system, a contraceptive implant, or injectable contraception;
* Not planning to start use an intrauterine contraceptive device or system or injectable contraception in the next three months;
* Not have had surgical sterilization or plan to have it in the next three months;
* Not have medical contraindication to implant use, including lactation within first 6 weeks postpartum, acute deep venous thrombosis or pulmonary embolism, lupus, migraine with aura, unexplained vaginal bleeding, current or history of breast cancer,severe cirrhosis, liver tumors, history of stroke, and current or history of ischaemic heart disease;
* Be willing to return to the clinic for two follow-up visits over the next three months; and
* Be otherwise a good candidate for study participation based on investigator assessment
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT01684358
Study Brief:
Protocol Section:
NCT01684358