Ovarian Contribution to Androgen Production in Adolescent Girls

NCT01421810 | Unknown

• 1 other identifier: 15298
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Obesity; Hyperandrogenism

Outcome Measures

Primary Outcomes (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

  24 hours after administration of rhCG administration

Study Arms (1)

dexamethasone, rhCG (Ovidrel)

EXPERIMENTAL

rhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO

Drug: Dexamethasone; Drug: rhCG

Interventions

Dexamethasone DRUG

1 mg PO

dexamethasone, rhCG (Ovidrel)

rhCG DRUG

25 mcg IV

Also known as: (Ovidrel)

dexamethasone, rhCG (Ovidrel)

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• University of California, San Diego: collaborator

Study Sites (1)

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Hyperandrogenism

Interventions

Dexamethasone; Ovidrel

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Christine Burt Solorzano, MD

  University of Virginia Center for Research in Reproduction

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Pediatrics

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 23, 2011
• Study Start: March 10, 2011
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (1)