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NCT01422733
Effect of Longer-term Adrenal Suppression Using Low Dose Hydrocortisone on Androgen Overproduction
EARLY_PHASE1 trial testing Hydrocortisone in Hyperandrogenemia. Withdrawn.
17 July 2018
Quick facts
| Lead sponsor | University of Virginia |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Start date | 1 June 2018 |
| Primary completion | 17 July 2018 |
| Estimated completion | 17 July 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hydrocortisone (hydrocortisone) — full drug profile →
- dexamethasone (dexamethasone) — full drug profile →
- Cosyntropin — full drug profile →
- rhCG — full drug profile →
Conditions studied
- Hyperandrogenemia — all drugs for Hyperandrogenemia →
- Obesity — all drugs for Obesity →
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Sponsor
University of Virginia
Who can join
Adults 7 to 16, female only, with Hyperandrogenemia or Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01422733
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Trials testing the same drug.
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Other recruiting trials for Hyperandrogenemia
Currently open trials in the same condition.
- NCT06998238 — Evaluating the Influence of Diet-induced Weight Loss on Fat (Adipose) Tissue's Insulin Sensitivity and Testosterone Synt · NA · active not recruiting
Other University of Virginia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01422733 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Virginia
- Last refreshed: 19 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01422733.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing