Please select the eligibility criteria that correspond to the clinical trial below.
Title: Pharmacokinetics of Implanon in Obese Women
Brief Summary: Prior studies examining the pharmacokinetics, safety, and efficacy of the new etonogestrel-containing single rod implantable contraceptive device, Implanon, did not include women who exceeded 130% of ideal body weight. Yet, as these women comprise a significant portion of the U.S. population, studies of Implanon in obese women are essential. The proposed study represents an important first step in addressing the lack of data on Implanon in obese women. We aim to examine the pharmacokinetics of Implanon in obese women during the first 6 months of use and to provide data on the acceptability, side effect profile, and ease of insertion, palpation, and removal in these women. We also aim to collect samples for future validation studies of the use of the blood spot (finger-stick blood sample on filter paper) as a method of determining plasma etonogestrel.


Options:
A: Inclusion Criteria:

* premenopausal with a uterus and at least one ovary
* willing and able to sign the informed consent
* willing to comply with the study protocol and visit schedule
* have a body mass index of less than 25, or greater than or equal to 30
* weight stable

Exclusion Criteria:

* known or suspected pregnancy
* delivery (vaginal or cesarean) within 4 months of device insertion
* abortion (first or second trimester) within 4 months of device insertion
* contraindications to Implanon use
* hemophilia
* undiagnosed abnormal genital bleeding
* hypersensitivity or allergy to any components of Implanon
* personal or family history of thrombosis or thromboembolic disorders
* hepatic tumors or active liver disease
* known or suspected carcinoma of the breast or history of breast cancer
* more that one cardiovascular risk factor such as hypertension or diabetes
* known history of PCOS, diabetes, or glucose abnormality
* present use or use within 2 months of device insertion of a CYP3A4 inducer
* breastfeeding women
* use of an investigational drug within 2 months of device insertion
* use of injectable contraception within 6 months of device insertion
* planning a pregnancy in the next 12 months
* known HIV infection
* smoking over the age of 35
B: Inclusion Criteria:

* Age between 18 and 35 years (inclusive), in good general health and requesting contraception.
* Has regular menstrual cycles (length of cycle 21-35 days) (i.e., endogenous cyclicity without hormonal contraceptive use).

Exclusion Criteria:

* Known or suspected pregnancy or is lactating.
* History of ectopic pregnancies.
* Any genital infection (until successfully treated).
* Abnormal uterine bleeding of unknown origin.
C: Inclusion Criteria:

* Woman using contraceptive implant for more than 12 months
* English or Spanish-speaking

Exclusion Criteria:

* None
D: Inclusion Criteria:

* Age 18-35
* BMI \> 30kg/m2
* Proof of a normal breast and pelvic exam within last 9 months
* Self reported normal menstrual periods (24-35 days)
* Good general health
* In the investigator's opinion, are subject's veins suitable the repeat blood draws dictated by study protocol
* Single progesterone level during screening visit ≥ 3ng/mL
* Hematocrit ≥ 36%

Exclusion Criteria:

* Contradictions to COCs (history of deep vein thrombosis,myocardial infection, uncontrolled hypertension, pulmonary embolus, diabetes with vascular changes, stroke, migraines with neurologic changes, breast cancer, impaired liver function, uncontrolled thyroid disease, hypersensitivity or allergy to birth control)
* Smoker (must smoke 0 cigarettes)
* Actively seeking/involved in a weight loss program
* Currently pregnant/seeking pregnancy in the next 6 months
* Currently breast-feeding
* Past or current diagnosis of polycystic ovarian disease
* Recent use of birth control (Depot medroxyprogesterone: 6 months, Progestin implants: 6 months, Oral contraceptives, patch or ring: 2 months, Hormone impregnated IUD: 6 months)
* Currently taking medication that interferes with COC's (Rifampin, Carbamazepine, St. John's Wort)

Answer: A