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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT02689804
Eligibility Criteria:
Inclusion Criteria:
* Women aged 18-45 years
* English-speaking
* BMI 18.5-24.9 kg/m2 or obese BMI 30.0-39.9 kg/m2
* Regular menstrual cycles
* No use of medroxyprogesterone acetate at least 6 months prior to study enrollment, unless resumption of two menstrual cycles
* No use of levonorgestrel intrauterine system (levonorgestrel-IUS), etonogestrel implant or combined hormonal contraception at least one month prior to the study and resumption of one menstrual cycle
* Women who are postpartum or post-abortion will be included if they have had at least one menstrual cycle since their last pregnancy
Exclusion Criteria:
* Prior allergic reaction to LNG-EC or UPA-EC
* Use of hormonal emergency contraception within the past month
* Women who are currently pregnant or who are currently breastfeeding
* History of cancer other than non-melanoma skin cancer
* Medical or surgical conditions or conditions requiring therapies known to impact sex steroid production or metabolism
* Use of HAART therapy for management of HIV infection
* Concomitant use of CYP3A4 inducers like rifampin, barbiturates, carbamazepine, lamotrigine, bosentan, felbamate, griseofulvin, oxcarbazepine, phenytoin, St. John's Wort and topiramate
* Current participation in any other trial of an investigational medicine or device in the three months leading up to this study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02689804
Study Brief:
Protocol Section:
NCT02689804