Clinical trial: Determining How Quickly Progesterone Slows LH Pulse Frequency (NCT00594217)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects will be healthy women in two groups: (1) women with regular menstrual cycles
             and no evidence of hyperandrogenism, and (2) women with PCOS (defined as
             clinical/biochemical evidence of hyperandrogenism plus oligomenorrhea, but with no
             evidence for other endocrinopathies).

          -  Subjects will be 18-35 years old.

          -  Subjects will be willing to strictly avoid pregnancy (using non-hormonal methods)
             during the time of study and must be willing and able to provide informed consent.

        Exclusion Criteria:

          -  We will exclude women with a history of any disorders that may potentially be
             complicated by hormonal treatment, such as DVT and breast, ovarian, or endometrial
             cancer.

          -  We will exclude women with any other cancer diagnosis and/or treatment (with the
             exception of basal cell or squamous skin carcinoma) unless they have remained
             clinically disease free (based on appropriate surveillance) for five years.

          -  Women with anemia (hematocrit < 36% and/or a hemoglobin level <12 g/dl) will be
             treated with iron for a maximum of 2 sequential months before the 1st admission and/or
             before the 2nd admission. If they remain anemic after 2 sequential months of ferrous
             gluconate (325 mg bid), they will then be excluded from further participation in the
             study.

          -  Women with a history of any disorders that may potentially be complicated by long-term
             iron supplementation, such as hemochromatosis and polycythemia vera, will be excluded.

          -  Women with a significant history of cardiac or pulmonary dysfunction (e.g., known or
             suspected congestive heart failure; known or suspected coronary atherosclerosis;
             asthma requiring systemic intermittent corticosteroids; etc.) will be excluded.

          -  Women with liver enzymes, alkaline phosphatase, or bilirubin > 1.5 times upper limit
             of normal (confirmed on repeat) will be excluded, with the exception that mild
             bilirubin elevations will be accepted in the setting of known Gilbert's syndrome.

          -  Abnormal sodium or potassium concentrations (confirmed on repeat); bicarbonate
             concentrations <20 or >30 (confirmed on repeat)

          -  Women with abnormal renal function (i.e., serum creatinine > 1.4) will be excluded
             (confirmed on repeat)

          -  Pregnant and breast-feeding women will be excluded.

          -  A history of allergy to progesterone or estradiol will constitute grounds for
             exclusion.

          -  Women with a BMI greater or equal to 40 kg/m2.

          -  Virilization

          -  A total testosterone > 150 ng/dl in women with PCOS (which suggests the possibility of
             a virilizing neoplasm) (confirmed on repeat)

          -  Elevated DHEAS (mild elevations may be seen in PCOS, and elevations < 1.5 times the
             upper limit of normal will be accepted in PCOS) (confirmed on repeat)

          -  Follicular 17-hydroxyprogesterone > 300 ng/dl, which suggests the possibility of
             congenital adrenal hyperplasia (if elevated during the luteal phase and there is a
             concern about the possibility of congenital adrenal hyperplasia, the
             17-hydroxyprogesterone may be collected during the follicular phase, or >60 if
             oligomenorrheic). NOTE: If a 17-hydroxyprogesterone > 300 ng/dl is confirmed on repeat
             testing, an ACTH stimulated 17-hydroxyprogesterone < 1000 ng/dl will be required for
             study participation.

          -  A previous diagnosis of diabetes, a fasting glucose ≥ 126 mg/dl, or a hemoglobin A1c >
             6.5%

          -  Abnormal TSH (subjects with adequately treated hypothyroidism, reflected by normal TSH
             values, will not be excluded; or, for a new diagnosis of hypothyroidism, further study
             will at the least be delayed pending appropriate treatment) (confirmed on repeat)

          -  Abnormal prolactin (mild elevations may be seen in PCOS, and elevations < 1.5 times
             the upper limit of normal will be accepted in this group) (confirmed on repeat)

          -  Evidence of Cushing's syndrome by history or physical exam

          -  Due to the amount of blood being drawn in the study, subjects with body weight < 110
             lbs. will be excluded from the study
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0