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Polycystic Ovary Syndrome | Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome research study

What is the primary objective of this study?

Jeffrey Chang MD is conducting a research study to learn more about the increased male hormone levels, otherwise known as androgens, seen in women with polycystic ovary syndrome (PCOS). Women with PCOS have ovaries that are comprised of many cysts, or follicles. They also have irregular or absent menstrual periods and symptoms of increased male hormones, such as facial hair or acne. In each part of the study (except part 4 which is for PCOS women only) we will be comparing responses of PCOS women to normal controls

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Polycystic Ovary Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:3-D UltrasoundOne time pelvic ultrasound

Drug:recombinant human chorionic gonadotropinRecombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards

Drug:Recombinant human follicle stimulating hormoneRecombinant human follicle stimulating hormone will be given iv and blood samples obtained before and 24 hr later.

Drug:AdrenocorticotropinEach subject will receive a 7 hr dose-response infusion of Adrenocorticotropin.

Drug:DexamethasoneDexamethasone will be given prior to ACTH infusion test.

Drug:GlucoseEach subject will undergo 3 oral glcuose tolerance tests.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PCOS womenEach subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH). After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH. After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above.

Normal womenEach subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH). After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH. After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above.

Study Status

Completed

Start Date: September 2009

Completed Date: September 2013

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls

Secondary Outcome: Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls

Study sponsors, principal investigator, and references

Principal Investigator: R. Jeffrey Chang, M.D.

Lead Sponsor: University of California, San Diego

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00989781

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