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Effect of Spironolactone on Adrenal or Ovarian Androgen Production in Overweight Pubertal Girls With Androgen Excess | Clinical Trials | Clareo Health

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

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

NCT01422759•University of Virginia

View on ClinicalTrials.gov

Summary

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

Detailed Description

This study will test whether spironolactone administration can ameliorate androgen (male hormone) overproduction in overweight pubertal girls with androgen excess. The investigators hypothesize that reduction in P450c17alpha overactivity and androgen receptor blockade by 12 weeks of spironolactone administration will improve androgen levels after adrenal stimulation testing with adrenocorticotropic hormone (ACTH) and ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).

Eligibility

Age

7 - 18 years

Sex

FEMALE

Healthy Volunteers

Inclusion 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)

Exclusion Criteria

•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
+8 more criteria

Locations (1)

University of Virginia Center for Research in Reproduction

Charlottesville, Virginia, United States

Key Dates

Start Date

December 9, 2016

Primary Completion Date

December 1, 2024

Completion Date

December 1, 2024

Last Updated

October 27, 2023

Enrollment

ESTIMATED participants

Conditions

ObesityHyperandrogenemiaPolycystic Ovary Syndrome

Interventions

Spironolactone

DRUG

Contacts

Melissa Gilrain

CONTACT

434-243-6911 pcos@virginia.edu

Christine Burt Solorzano, MD

CONTACT

434-243-6911 pcos@virginia.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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