The purpose of the blood spot validation portion of the study is to test if measuring female
hormone levels in the blood is as accurate through a finger stick, as it is by a blood draw
from a vein. The purpose of the feasibility study is to evaluate ovulation occurrence in two
populations of oral contraceptive users: heavier and lighter women.
The blood spot validation portion of the study tests the hypothesis that progesterone assays
from self-collected daily blood spots are equivalent to serum samples, and that the values
obtained can identify women that ovulate. After validating collection methods, enrollment
will begin for the feasibility portion of the study looking at thin and heavy women on birth
control pills. All women in this portion of the study will take a very-low dose birth
control pill that is normally available through a doctor's office. During each month of the
study, women will have their blood pressure and weight recorded, and have their blood drawn
twice per week or use a finger stick kit daily at home to check for the natural hormones and
brain chemicals that tells if an egg develops. During the last week of each menstrual cycle
(period week), women will also have their blood drawn to measure the levels of hormone found
in the birth control pill. Women will also need to report in a written diary that they have
taken their birth control pill for the day.
- age 18 to 35
- single baseline hematocrit ≥ 36%
- single progesterone level of 3 ng/mL or greater during the luteal phase (days 18 to
25) in the menstrual cycle prior to treatment with OCs.
- any absolute contraindications to ethinyl estradiol and levonorgestrel
- actively seeking or involved in a weight loss program (must be weight stable)
- pregnancy, breastfeeding, or seeking pregnancy
- diagnosis of Polycystic Ovarian Syndrome
- recent (8 week) use of OC (patch or ring included), intrauterine, or implantable
- DepoProvera use within six months
- current use of drugs that interfere with metabolism of sex steroids.