Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome

NCT00989781 | Completed Results DMC

• 1 other identifier: 090560
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, Androgens, ovary, polycystic

Outcome Measures

Primary Outcomes (1)

• 17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls

  Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection

  Baseline and 24 hours after hCG

Secondary Outcomes (3)

• Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls

  Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH

• 17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.

  Baseline and 24 after hCG

• Anti-Mullerian Hormone (AMH)

  Baseline

Other Outcomes (1)

• Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls

  baseline

Study Arms (2)

PCOS women

EXPERIMENTAL

Each 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.

Radiation: 3-D Ultrasound; Drug: recombinant human chorionic gonadotropin; Drug: Recombinant human follicle stimulating hormone; Drug: Adrenocorticotropin; Drug: Dexamethasone; Drug: Glucose

Normal women

EXPERIMENTAL

Each 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.

Radiation: 3-D Ultrasound; Drug: recombinant human chorionic gonadotropin; Drug: Recombinant human follicle stimulating hormone; Drug: Adrenocorticotropin; Drug: Dexamethasone; Drug: Glucose

Interventions

3-D Ultrasound RADIATION

One time pelvic ultrasound

Normal women; PCOS women

recombinant human chorionic gonadotropin DRUG

Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards

Also known as: Ovidrel, r-hCG

Normal women; PCOS women

Recombinant human follicle stimulating hormone DRUG

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

Also known as: Gonal-F, r-hFSH

Normal women; PCOS women

Adrenocorticotropin DRUG

Each subject will receive a 7 hr dose-response infusion of Adrenocorticotropin.

Also known as: Cosyntropin, ACTH

Normal women; PCOS women

Dexamethasone DRUG

Dexamethasone will be given prior to ACTH infusion test.

Also known as: corticosteroid

Normal women; PCOS women

Glucose DRUG

Each subject will undergo 3 oral glcuose tolerance tests.

Also known as: sugar

Normal women; PCOS women

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Chorionic Gonadotropin; Ovidrel; follitropin alfa; Adrenocorticotropic Hormone; Cosyntropin; Dexamethasone; Adrenal Cortex Hormones; Glucose; Sugars

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Nerve Tissue Proteins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hexoses; Monosaccharides; Carbohydrates

Results Point of Contact

• Title: R. Jeffrey Chang, M.D.
• Organization: UCSD

rjchang@ucsd.edu

858-534-8930

Study Officials

• R. Jeffrey Chang, M.D.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: October 6, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 4, 2018
• Results First Posted: October 17, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)