Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 21 January 2013
• Main ID: NCT00989781
• Date of registration: 05/10/2009
• Primary sponsor: University of California, San Diego
• Public title: Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
• Scientific title: Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
• Date of first enrolment: September 2009
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00989781
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Countries of recruitment

United States

Contacts

• Name: Kevin Maas, M.D., Ph.D.

• Name: Kevin Maas, M.D., Ph.D.

• Name: R. Jeffrey Chang, M.D.
• Affiliation: Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

A group of 40 women with PCOS and 20 normal women ages 18-37 will be studied.

- Subjects will be determined to have PCOS based on clinical history of irregular
menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries
on ultrasound.

- Subjects should not have been on any hormonal therapy or metformin for at least 2
months prior to study start.

- Subjects will be determined to be normal controls if they have a clinical history of
regular periods

Exclusion Criteria:

- Women with hemoglobin less than 11 gm/dl at screening evaluation

- Women with untreated thyroid abnormalities

- Pregnant women or women who are nursing

- Women with BMI > 37

- Women with known sensitivity to the agents being used

- Women with prosthetic devices (i.e.,ear)/ shunts (ventricular), Hearing aids, Metal
plate/pins/screws/wires

- Women with diabetes, or renal, liver, or heart disease.



Age minimum: 18 Years
Age maximum: 37 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Polycystic Ovary Syndrome

Intervention(s)

Drug: Adrenocorticotropin

Drug: Dexamethasone

Drug: Glucose

Drug: Recombinant follicle stimulating hormone

Drug: recombinant human chorionic gonadotropin

Radiation: 3-D Ultrasound

Primary Outcome(s)

17-hydroxyprogesterone responses to hCG with and without FSH in PCOS women and normal controls [Time Frame: up to 2 years]

Secondary Outcome(s)

17-hydroxyprogesterone response to hCG in the setting of reduced insulin secretion in PCOS women [Time Frame: 09/2013]

Adrenal androgen response to ACTH in PCOS women and normal controls [Time Frame: up to 2 years]

Follicle count on 3-D Ultrasound in PCOS women and normal controls [Time Frame: up to 2 years]

Secondary ID(s)

090560

Source(s) of Monetary Support

Please refer to primary and secondary sponsors