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:
NCT01930994
Eligibility Criteria:
Inclusion Criteria:
* Have a Sino-implant (II) or Jadelle implant set in place, confirmed by physical exam;
* Have a confirmed contraceptive implant insertion date consistent with the criteria for the cohort she is to be enrolled in;
* Be aged between 18 and 44 years, inclusive;
* Not wish to become pregnant in the next six months;
* Not desire implant removal within the next six months.
* Be able to understand the information given to them and to make personal decisions on whether to participate or not in the study;
* Consent to participation, and sign an informed consent form;
* Agree and be able to return to the clinic for the second study visit.
Exclusion Criteria: The following criteria exclude participation in the study:
* Use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's wort (Hypericum perforatum), by self-report;7
* Use of medications containing LNG or other hormones that impact LNG or SHBG disposition, e.g. treatment with LNG or oral contraceptives for bleeding disturbances, by self-report;
* Use of anti-retroviral drugs, by self-report;
* Any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT01930994
Study Brief:
Protocol Section:
NCT01930994