Clinical trial · Interventional
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)
NCT01422707CI-TRIAL-00033861withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study team decided not to pursue this study.
Summary
Brief summary (as posted)
Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperandrogenemia | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrocortisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- hydrocortisone
- description
- 4 weeks hydrocortisone with pre- and post-intervention Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing
- interventionNames
- Drug: Hydrocortisone
Primary outcomes (1)
- measure
- Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks
- timeFrame
- 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration
Secondary outcomes (1)
- measure
- Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration
- timeFrame
- 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 7 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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: * 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 * 17-hydroxyprogesterone \>295 ng/dL * History of Cushing's syndrome or adrenal insufficiency * Pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.