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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT02210702
Eligibility Criteria:
Inclusion Criteria:
* 18-45 year old women who desire contraception postpartum for at least 6 weeks.
* 18-45 year old women who choose not to use oral contraceptive medication postpartum for at least 6 weeks for the control group.
Exclusion Criteria (Medication groups):
* Breastfeeding (although this may limit participant enrollment, combined oral contraceptives are contraindicated in this population).
* Delivery by cesarean section.
* Previous history of depression, mood disorders, or psychiatric disorders.
* Any condition (history or presence of) which contraindicates the use of combination OCs, including:
* Thrombophlebitis or thromboembolic disorders, known or suspected clotting disorders, deep vein thrombosis, thrombogenic valvulopathies or rhythm disorders.
* Pulmonary Embolism.
* Cerebrovascular or coronary artery disease or myocardial infarction.
* Diabetes mellitus.
* Migraine headaches with focal, neurological symptoms.
* Chronic renal disease.
* Uncontrolled or untreated hypertension.
* Cholestatic jaundice.
* Known or suspected carcinoma of the breast, endometrial carcinoma, or known or suspected estrogen-dependent neoplasia.
* Impaired liver function or disease, hepatic adenomas or carcinomas.
* Known hypersensitivity to estrogens and/or progestins.
* History of thyroid disorders.
* Recent alcohol or drug use.
* Smoking and age ≥35 or smokers who will become 35 years of age during the study.
* Known history of noncompliance with taking medication.
Exclusion Criteria (Control group):
* Previous history of depression, mood disorders, or psychiatric disorders.
* Recent alcohol or drug use.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02210702
Study Brief:
Protocol Section:
NCT02210702