Ovarian Contribution to Androgen Production in Adolescent Girls (CBS001)

This study is currently recruiting participants.
Verified June 2012 by University of Virginia
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Christine Burt Solorzano, University of Virginia
ClinicalTrials.gov Identifier:
NCT01421810
First received: August 17, 2011
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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 Intervention
Polycystic Ovary Syndrome
Obesity
Hyperandrogenism
Drug: Dexamethasone
Drug: r-hCG (Ovidrel)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Ovarian Contribution to Androgen Production in Adolescent Girls

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin administration in normal weight and overweight girls across puberty [ Time Frame: 24 hours after administration of human chorionic gonadotropin (r-hCG) administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2010
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexamethasone, r-hCG (Ovidrel)
r-hCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO
Drug: Dexamethasone
1 mg PO
Drug: r-hCG (Ovidrel)
25 mcg IV

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 LH, lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin and decreased FSH and/or SHBG

Exclusion Criteria:

  • Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR12702/JCM022. This protocol is designed to allow subjects enrolling in IRB-HSR12702/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-HSR12702/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 ACTH-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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421810

Contacts
Contact: Michelle Y. Abshire, PhD 434-243-6911 pcos@virginia.edu
Contact: Christine Burt Solorzano, MD 434-243-6911 pcos@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Research in Reproduction Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Michelle Y Abshire, PhD    434-243-6911    pcos@virginia.edu   
Principal Investigator: Christine Burt Solorzano, MD         
Sponsors and Collaborators
University of Virginia
University of California, San Diego
Investigators
Principal Investigator: Christine Burt Solorzano, MD University of Virginia Center for Research in Reproduction
  More Information

No publications provided

Responsible Party: Christine Burt Solorzano, Assistant Professor in Pediatrics, University of Virginia
ClinicalTrials.gov Identifier: NCT01421810     History of Changes
Other Study ID Numbers: 15298
Study First Received: August 17, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Cysts
Obesity
Polycystic Ovary Syndrome
Hyperandrogenism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Androgens
Chorionic Gonadotropin
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014