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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01594632
Eligibility Criteria:
Inclusion Criteria:• In good general health
* Aged between 18 and 44 years, inclusive
* Not pregnant
* Not lactating
* Not wishing to become pregnant in the next five years
* Request long-acting reversible contraception
* If previously used injectable contraceptives for pregnancy prevention, be more than 9 months since last injection of Depo-Provera and more than 3 months after the last injection of a combined injectable contraceptive
* If previously used LNG-containing oral pills or implants, be more than 1 week after last hormone intake or implant removal
* Be able to understand the information provided and to make personal decisions on participation
* Consent to participation and sign a consent form
* Agree and be able to return to the clinic for follow-up visits over five years
Exclusion Criteria:
* acute deep venous thrombosis and/or pulmonary embolism or history of thromboembolic disease
* systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
* unexplained vaginal bleeding
* current or history of breast cancer
* acute liver disease or cirrhosis
* benign or malignant tumor of the liver
* use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's Wort (Hypericum perforatum)
* more than one sexual partner in the last 3 months
* diagnosis or treatment for a sexually transmitted infection (STI) within the past 30 days for her or partner (excluding recurrent genital herpes or condyloma)
* known HIV positive status for her or partner
* 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
* BMI greater than or equal to 30 (for the sub-group of women with intensive LNG sampling)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT01594632
Study Brief:
Protocol Section:
NCT01594632