Determination if Oral DCI Administration to Women With PCOS Increases Total DCI Content in Urine and Blood...
A total of 46 women will be studied. We will study 23 obese and 23 non-obese women. There
will be no BMI restriction. Twenty-three women will be randomly assigned to receive DCI
(experimental group) and 23 women to receive placebo (control group). The women will be
studied during the equivalent of the follicular phase of the cycle, as documented by a serum
progesterone concentration of 2 ng/ml.
PCOS will be defined using criteria developed at the 1990 NICHD conference on PCOS3 - i.e.,
all women will have oligomenorrhea (eight or fewer menstrual periods annually) and
hyperandrogenemia (elevated serum total or free testosterone concentration), and secondary
causes of hyperandrogenism or ovulatory dysfunction will be excluded (see below: Entrance
Criteria). All women will undergo a standard oral glucose tolerance test (OGTT) to screen
for diabetes mellitus,16 but impaired glucose tolerance (IGT) will not be an exclusion
criteria because of the high prevalence of IGT in this population.8,17-19 We intentionally
will not screen the women for the presence of insulin resistance. Women with PCOS who have
disorders associated with insulin resistance - such as hypertension21-23 or
dyslipidemia21-23 - will not be excluded as long as they have been on a stable dose of
medication for 6 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood.
John E. Nestler, MD
Virginia Commonwealth University
United States: Food and Drug Administration
|General Clinical Research Center||Richmond, Virginia 23298|