Study Stopped
The study team decided not to pursue this study.
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2018
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedStudy Start
First participant enrolled
January 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2018
CompletedJuly 19, 2018
July 1, 2018
6 months
August 19, 2011
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks
30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration
Secondary Outcomes (1)
Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration
30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration
Study Arms (1)
hydrocortisone
EXPERIMENTAL4 weeks hydrocortisone with pre- and post-intervention Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Screening labs outside of age-appropriate normal range
- Hemoglobin \<12 mg/dL and hematocrit\<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still \<36%, they will be excluded.)
- Morning Cortisol \<5 g/dL
- hydroxyprogesterone \>295 ng/dL
- History of Cushing's syndrome or adrenal insufficiency
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine M. Burt Solorzano, MD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
August 19, 2011
First Posted
August 24, 2011
Study Start
January 19, 2018
Primary Completion
July 17, 2018
Study Completion
July 17, 2018
Last Updated
July 19, 2018
Record last verified: 2018-07