Trial · Interventional
WithdrawnEarly phase 1Registry dataEffect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: The study team decided not to pursue this study.
Overview
- Status
- Withdrawn
- Phase
- Early phase 1
- Enrollment
- 0 participants (actual)
- Sponsor
- University of Virginia · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 1 Jun 2018
- Primary completion
- 17 Jul 2018
- Completion
- 17 Jul 2018
- First posted
- 24 Aug 2011 (estimated)
- Last update posted
- 19 Jul 2018
- Conditions
- Hyperandrogenemia · Obesity · Polycystic Ovary Syndrome
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph Early 1Withdrawn
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction
NCT014227331 Jun 2018 to 17 Jul 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will test whether longer-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight early pubertal girls with androgen excess. The investigators hypothesize that suppression of nighttime adrenocorticotropin hormone (ACTH) production by 12 weeks of evening oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with ACTH or ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
Interventions
- HydrocortisoneDrug
- dexamethasoneDrug
- CosyntropinDrug
- rhCGDrug
Arms1
Experimental
hydrocortisone, dexamethasone, Cosyntropin (ACTH), rhCG
12 weeks hydrocortisone, dexamethasone, and Cosyntropin (ACTH) to perform standardized adrenal stimulation testing; dexamethasone, and rhCG to perform standardized ovarian stimulation testing
Primary outcomes1
Outcomes the sponsor listed as primary.
Changes in free testosterone or 17-hydroxyprogesterone levels after ACTH and rhCG administration respectively, before and after hydrocortisone administration for 12 weeks
Time frame · 12 weeks after hydrocortisone administration
Secondary outcomes(2)
Changes in adrenal and ovarian steroid precursors after ACTH and rhCG; body composition via air displacement plethysmography, BMI, and glucose tolerance testing results; baseline and after 12 weeks of hydrocortisone administration
Time frame · 12 weeks after hydrocortisone administration
Morning cortisol
Time frame · 72 hours following discontinuation of hydrocortisone
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 7 Years up to 16 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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