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Ovarian Contribution to Androgen Production in Adolescent Girls (CBS001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01421810
Recruitment Status : Recruiting
First Posted : August 23, 2011
Last Update Posted : August 30, 2019
University of California, San Diego
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia

Brief Summary:
Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Obesity Hyperandrogenism Drug: Dexamethasone Drug: rhCG Not Applicable

Detailed Description:
Adolescent hyperandrogenemia can represent a forerunner to adult PCOS. Because adrenarche leads to an increase in adrenal androgen production during early puberty and since early puberty is associated with an overnight rise in testosterone that follows a similar time course to cortisol, we hypothesize that the adrenal gland is a major source of androgens in early puberty. On the other hand, the overnight rise in testosterone may reflect an ovarian response to overnight increases of gonadotropin secretion in early puberty. However, the ability of the ovaries to produce androgens (e.g., to respond to gonadotropin stimulation) during early puberty has not been tested concurrently in these girls. The sources of excess androgen production and the timing of their relative contributions across puberty are important in understanding the mechanism of hyperandrogenemia in these individuals. In addition, determination of the sources of hyperandrogenemia across puberty may have clinical utility in the development of preclinical screening tests designed to reveal those girls at greatest risk for PCOS and identification of potential therapeutic targets to prevent its development.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Ovarian Contribution to Androgen Production in Adolescent Girls
Study Start Date : December 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: dexamethasone, rhCG (Ovidrel)
rhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO
Drug: Dexamethasone
1 mg PO

Drug: rhCG
25 mcg IV
Other Name: (Ovidrel)

Primary Outcome Measures :
  1. Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty [ Time Frame: 24 hours after administration of rhCG administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Girls age 7-18 years
  • Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile)
  • With or without signs of excess androgen
  • Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)

Exclusion Criteria:

  • Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR #12702/JCM022. This protocol is designed to allow subjects enrolling in IRB-HSR #12702/JCM022 to simultaneously participate in this companion protocol.
  • Inability to comprehend what will be done during the study or why it will be done
  • BMI-for-age < 5th percentile
  • Weight < 27 kg if simultaneously participating in IRB-HSR #12702/JCM022 due to blood volume limits
  • Obesity associated with a diagnosed genetic syndrome (e.g. Prader-Willi syndrome)
  • Since the study involves looking at ovarian function, boys will be excluded.
  • Positive pregnancy test or lactation. Subjects with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors. However, the screening physician will encourage them to tell their parent(s) and counsel them about the importance of appropriate prenatal care and counseling. We will arrange follow-up for them at the Teen Health Clinic at the University of Virginia or their primary care physician's office in a timely manner.
  • Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error.
  • Morning cortisol < 3 microgram/dL or history of Cushing syndrome or adrenal insufficiency
  • History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 ng/dL, which suggests the possibility of congenital adrenal hyperplasia (if postmenarchal, the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40 days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >300 mg/dL is confirmed on repeat testing, an adrenocorticotropic hormone-stimulated 17-hydroxyprogesterone <1000 ng/dL will be required for study participation.
  • Total testosterone > 150 ng/dL
  • Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c >6.5%
  • Abnormal thyroid stimulating hormone (TSH) for age. Subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded.
  • Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations <1.5 times the upper limit of normal will be accepted in this group.
  • Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for up to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral ferrous gluconate daily (containing 36 mg elemental iron); subjects weighing >36 kg will take two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg elemental iron each). They will return to the Clinical Research Unit (CRU) or alternate UVA clinical unit after 30-60 days of iron therapy to have their hemoglobin or hematocrit rechecked and will proceed with the remainder of the study if it is ≥12 g/dL or ≥36%, respectively.
  • Persistent liver test abnormalities, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Mild elevations may be seen in overweight girls, so elevations <1.5 times the upper limit of normal will be accepted in this group.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421810

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Contact: Melissa Gilrain 434-243-6911
Contact: Christine Burt Solorzano, MD 434-243-6911

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United States, Virginia
University of Virginia Center for Research in Reproduction Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Melissa Gilrain    434-243-6911   
Principal Investigator: Christine Burt Solorzano, MD         
Sponsors and Collaborators
University of Virginia
University of California, San Diego
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Principal Investigator: Christine Burt Solorzano, MD University of Virginia Center for Research in Reproduction
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Responsible Party: Christine Burt Solorzano, Assistant Professor in Pediatrics, University of Virginia Identifier: NCT01421810    
Other Study ID Numbers: 15298
First Posted: August 23, 2011    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents