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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00789802
Eligibility Criteria:
Inclusion Criteria:
* Must be of reproductive age from 18 to 45 years
* Must be choosing LNG-IUC for contraception
* Must be English-speaking
* Be willing to avoid additional use of exogenous hormones, such as oral contraceptives, for the duration of the study
* Be willing to avoid additional use of nonsteroidal antiinflammatory drugs, such as ibuprofen or aspirin for the duration of the study
* Be willing to comply with the study protocol, keep the bleeding diary and comply with follow-up visits and telephone interviews as scheduled
* Be willing and able to provide informed consent
Exclusion Criteria:
* Known or suspected pregnancy
* Contraindication to estrogen use, such as presence or history of:
* venous thromboembolism
* Arterial thrombosis
* Thrombophilia disorders, or known family history of
* Hypertension
* Migraine headaches with aura or focal neurologic involvement, or any migraine over age 35 years
* Recent or planned future major surgery which will result in prolonged immobilization during the study period
* Presence or history of severe hepatic disease or liver tumors
* Known or suspected estrogen-dependent neoplasm
* Vaginal bleeding of unknown etiology
* Any cigarette smoking and age over 35 years
* Contraindications to nonsteroidal anti-inflammatory use, such as presence or history of:
* Gastrointestinal ulcer disease
* Renal insufficiency or failure
* Aspirin-induced asthma or hypersensitivity reaction
* Systemic lupus erythematosus (SLE) and mixed connective tissue disorders
* Use of anticoagulants
* Cardiovascular disease
* Use of medications that alter estrogen metabolism, i.e. rifampin, certain anti-seizure medications
* Regular use of an NSAID
* Current diagnosis of menorrhagia, metrorrhagia, symptomatic uterine fibroids, or endometrial polyp
* Hypersensitivity or allergy to any of the components of the estradiol patch
* Use of injectable contraception within 6 months of the start of the study medication
* Delivery or abortion in the previous 4 weeks
* Prior use of LNG-IUD
* Any condition, that in the opinion of the investigator, would contraindicate study participation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00789802
Study Brief:
Protocol Section:
NCT00789802