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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00480532
Eligibility Criteria:
Inclusion Criteria:
* General good health
* Willing and able to agree to randomization and sign informed consent
* Currently having regular menstrual cycles (24-36 days), with combined cyclic hormonal method (COCs, Nuva Ring, Ortho Evra), without intermenstrual bleeding in last 2 years.
Exclusion Criteria:
* Intrauterine device (IUD) in place
* Abnormal pap smear that has not been treated or followed up
* Those with hypersensitivity reactions to doxycycline or any of the tetracyclines
* Use of depomedroxyprogesterone acetate within 9 months of the start of the study.
* Use of hormonal medications (excluding cyclic contraceptives and plan B) within 2 months of the start of the study.
* Any one unwilling to keep a daily menstrual diary or otherwise unwilling to follow the study criteria
* Currently taking medications that interfere with COCs (rifampin, carbamazepine, St. Johns wort)
* Currently has a progestin implant
* Positive Gonorrhea or Chlamydia cultures at enrollment examination
* Smoking more than 5 cigarettes per month
* Any medical condition that is a contraindication to the use of COCs in accordance with product labeling including:
* History of thrombophlebitis, deep venous thrombosis, thrombogenic vasculopathies, thrombogenic rhythm disorders or thromboembolic disorders
* Current or past history of cerebrovascular or coronary artery disease
* Scheduled major surgery in the next six months with prolonged immobilization
* Diabetes with vascular involvement
* Headache with focal neurologic symptoms
* Uncontrolled hypertension
* Suspected or known carcinoma of the breast or personal history of breast cancer
* Carcinoma of the endometrium or other known or suspected estrogen dependent neoplasms
* Undiagnosed genital bleeding
* History of cholestatic jaundice of pregnancy or cholestatic jaundice with prior oral contraceptive use
* Hepatic adenoma or carcinoma or active liver disease if liver function has not returned to normal
* Known or suspected pregnancy
* Hypersensitivity to estrogen or progesterone containing products
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00480532
Study Brief:
Protocol Section:
NCT00480532