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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT06250205
Eligibility Criteria:
Inclusion Criteria:
* Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
* Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
* If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below
Exclusion Criteria:
* Male
* Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
* History of Hypertension, or seated blood pressure for a minimum of 5 minutes \>140mmHg systolic, or \> 80 mmHg, diastolic at screening
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT06250205
Study Brief:
Protocol Section:
NCT06250205