NCT03905603 (SHK001) is a EARLY_PHASE1 clinical trial of ACTH in Polycystic Ovary Syndrome, sponsored by University of Virginia.

Who is sponsoring NCT03905603?

NCT03905603 is sponsored by University of Virginia.

What drugs are being tested in NCT03905603?

Interventions in NCT03905603: ACTH, rhCG.

What condition does NCT03905603 study?

NCT03905603 studies Polycystic Ovary Syndrome.

Is NCT03905603 still recruiting?

NCT03905603 is currently recruiting now. Last updated 3 November 2023.

Last reviewed 2023-11-03 · How we verify

NCT03905603: SHK001

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Relative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS

Recruiting now EARLY_PHASE1 Last updated 3 November 2023

What this trial tests

EARLY_PHASE1 trial testing ACTH in Polycystic Ovary Syndrome in 144 participants. Currently enrolling.

Timeline

8 October 2019

Primary endpoint
1 April 2026

1 May 2026

Quick facts

Lead sponsor	University of Virginia
Phase	EARLY_PHASE1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	144
Start date	8 October 2019
Primary completion	1 April 2026
Estimated completion	1 May 2026
Sites	1 location across United States

Drugs / interventions tested

ACTH — full drug profile →
rhCG — full drug profile →

Conditions studied

Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →

Sponsor

University of Virginia

Who can join

Adults 20 to 49, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the study is to determine the relative contributions of four established predictors of hyperandrogenism (luteinizing hormone \[LH\] secretion, ovarian response to recombinant human chorionic gonadotropin \[r-hCG\] administration, adrenal response to adrenocorticotropic hormone \[ACTH\] administration, and hyperinsulinemia) in older vs. young women with Polycystic Ovary Syndrome (PCOS) in a cross-sectional, physiological study. The investigators hypothesize that hyperinsulinemia is a stronger independent predictor of free testosterone (T) in older reproductive aged (vs. young) women with PCOS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of ACTH

Trials testing the same drug.

NCT02315872 — ACTH for Fatigue in Multiple Sclerosis Patients · Phase 3 · completed
NCT01950234 — ACTH in Progressive Forms of MS · Phase 2 · terminated

Other recruiting trials for Polycystic Ovary Syndrome

Currently open trials in the same condition.

NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting

Other University of Virginia trials

Trials by the same sponsor.

NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
NCT07036315 — Meaning in Music-Based Pain Modulation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03905603 (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: 3 November 2023

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/NCT03905603.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing