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Determination if Pharmacologic Blockade of Androgen Action Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-Stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS


N/A
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

Determination if Pharmacologic Blockade of Androgen Action Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-Stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS


Hyperinsulinemia stimulates ovarian production of androgens, especially testosterone, in
PCOS. Therefore, it is theoretically possible that testosterone increases uClDCI in PCOS,
and that this serves as the explanation for the correlation between uClDCI and insulin
sensitivity. While we regard this possibility as unlikely, it is important that it be
tested. To accomplish this, we will assess obese (BMI >30 kg/m2) women with and without
PCOS at baseline, and again after 4 weeks of androgen action blockade with the drug
flutamide. Flutamide is an antiandrogen that works by blocking the binding of androgens to
the androgen receptor.

We will determine if this pharmacologic blockade i) decreases the renal clearance of DCI,
ii) increases the circulating concentration of DCi, and iii) enhances the insulin-stimulated
release of the DCI-IPG mediator during an OGTT.


Inclusion Criteria:



(1) Obese (BMI≥30 kg/m2) women with PCOS between 18-40 years of age: i) oligomenorrhea (8
menstrual periods annually), ii) biochemical hyperandrogenemia (elevated total or free
testosterone), iii) normal thyroid function tests and serum prolactin, and iv) exclusion
of 21α-hydroxylase deficiency by a fasting 17α-hydroxyprogesterone <200 ng/dl.48, (2)
acceptable health on the basis of interview, medical history, physical examination, and
laboratory tests (CBC, SMA20, urinalysis, serum BhCG). (3) Signed, witnessed informed
consent. (4) 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.
(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.

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Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Outcome Measure:

DCI-IPG measurements in blood and urine

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

John E. Nestler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Federal Government

Study ID:

04487VCUIRB

NCT ID:

NCT00729560

Start Date:

July 2008

Completion Date:

February 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Polycystic Ovary Syndrome

Name

Location
Virginia Commonwealth University General Clinical Research Center Richmond, Virginia  23298