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Determination if Oral DCI Administration to Women With PCOS Increases Total DCI Content in Urine and Blood...


Phase 2/Phase 3
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

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.


Inclusion Criteria:

-

(1) Non-obese and obese women with PCOS between 18-40 years of age. (2) oligomenorrhea ( 8
menstrual periods annually), (3) biochemical hyperandrogenemia (elevated total or free
testosterone), (4) normal thyroid function tests and serum prolactin, and (5) exclusion of
21 -hydroxylase deficiency by a fasting 17 -hydroxyprogesterone <200 ng/dl.41 (6)
acceptable health on the basis of interview, medical history, physical examination, and
laboratory tests (CBC, SMA20, urinalysis). (7) Signed, witnessed informed consent. (8)
Ability to comply with study requirements.

Exclusion Criteria: - (1) Diabetes mellitus by fasting glucose or OGTT, or clinically
significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious,
neoplastic and malignant disease (other than non-melanoma skin cancer). (2) Current use
of oral contraceptives, DepoProvera or Norplant.. (3) Documented or suspected recent
(within one year) history of drug abuse or alcoholism. (4) Ingestion of any
investigational drug within two months prior to study onset.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Outcome Measure:

To determine if oral DCI administration to women with PCOS increases the total DCI content in urine and blood.

Outcome Time Frame:

43 days

Safety Issue:

No

Principal Investigator

John E. Nestler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Food and Drug Administration

Study ID:

2R01HD35629 P2

NCT ID:

NCT00497653

Start Date:

February 2001

Completion Date:

July 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic Ovary Syndrome

Name

Location
General Clinical Research Center Richmond, Virginia  23298