RECRUITING

Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess

Conditions

Obesity Hyperandrogenemia Polycystic Ovary Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Whether 12 weeks of spironolactone can reduce androgen production from ovaries and adrenal glands of girls with obesity and androgen excess

Official Title

Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess (CBS006)

Quick Facts

Study Start:2016-12-09

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01422759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Overweight(\>85th BMI%) females * Early to late puberty (expected age range 7-18) * Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage) * 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)	* Age \< 7 or \> 18 years * Inability to comprehend what will be done during the study or why it will be done * BMI-for-age \< 5th percentile * Positive pregnancy test or lactation. * Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error. * Morning cortisol \< 3 µg/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 postmenarcheal, 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, which suggests the possibility of a virilizing neoplasm * DHEAS greater than the upper limit of age-appropriate normal range (mild elevations may be seen in Polycystic Ovary Syndrome (PCOS) and adolescent Hyperandrogenemia (HA), and elevations \< 1.5 times the age-appropriate upper limit of normal will be accepted in these groups) * Virilization * Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c ≥6.5% * Abnormal thyroid stimulating hormone (TSH) for age. Subjects with stable and 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) 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. * Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.) * Abnormal sodium, potassium, or bicarbonate concentrations, or elevated creatinine concentration (confirmed on repeat) * No medications known to affect the reproductive system or glucose metabolism can be taken in the 3 months prior to the study. Such medications include oral contraceptive pills, progestins, metformin, glucocorticoids, and psychotropics.

Inclusion Criteria

Exclusion Criteria

* Overweight(\>85th BMI%) females
* Early to late puberty (expected age range 7-18)
* Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
* 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)

* Age \< 7 or \> 18 years
* Inability to comprehend what will be done during the study or why it will be done
* BMI-for-age \< 5th percentile
* Positive pregnancy test or lactation.
* Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error.
* Morning cortisol \< 3 µg/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 postmenarcheal, 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, which suggests the possibility of a virilizing neoplasm
* DHEAS greater than the upper limit of age-appropriate normal range (mild elevations may be seen in Polycystic Ovary Syndrome (PCOS) and adolescent Hyperandrogenemia (HA), and elevations \< 1.5 times the age-appropriate upper limit of normal will be accepted in these groups)
* Virilization
* Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c ≥6.5%
* Abnormal thyroid stimulating hormone (TSH) for age. Subjects with stable and 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) 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.
* Significant history of cardiac or pulmonary dysfunction (e.g., known or suspected congestive heart failure; asthma requiring intermittent systemic corticosteroids; etc.)
* Abnormal sodium, potassium, or bicarbonate concentrations, or elevated creatinine concentration (confirmed on repeat)
* No medications known to affect the reproductive system or glucose metabolism can be taken in the 3 months prior to the study. Such medications include oral contraceptive pills, progestins, metformin, glucocorticoids, and psychotropics.

Contacts and Locations

Study Contact

Melissa Gilrain

CONTACT

434-243-6911

pcos@virginia.edu

Christine Burt Solorzano, MD

CONTACT

434-243-6911

pcos@virginia.edu

Principal Investigator

Christine Burt Solorzano, MD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

Christine Burt Solorzano, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-12-09

Study Completion Date2024-12

Study Record Updates

Study Start Date2016-12-09

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Obesity
Hyperandrogenemia
Polycystic Ovary Syndrome