Trial · Interventional
Status unknownEarly phase 1Registry dataRelative Contributions of Predictors of Hyperandrogenism in Older vs. Young Women With PCOS
Short name SHK001
Overview
- Status
- Status unknown
- Phase
- Early phase 1
- Enrollment
- 144 participants (estimated)
- Sponsor
- University of Virginia · Other
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 8 Oct 2019
- Primary completion
- 1 Apr 2026 (estimated)
- Completion
- 1 May 2026 (estimated)
- First posted
- 5 Apr 2019
- Last update posted
- 3 Nov 2023
- Conditions
- Polycystic Ovary Syndrome
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph Early 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ACTHDrug
- rhCGDrug
Arms1
Experimental
ACTH (Cosyntropin), rhCG (Ovidrel)
ACTH (Cosyntropin) administered 250 mcg IV; rhCG (Ovidrel) administered 250 mcg IV
Primary outcomes5
Outcomes the sponsor listed as primary.
Change in calculated free testosterone concentrations
Time frame · baseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (ACTH), 24 hours after recombinant human chorionic gonadotropin (rhCG).
Registry description
pg/mL
Mean luteinizing hormone (LH) concentrations
Time frame · overnight frequent blood sampling (every 10 mininutes for 12 hours)
Registry description
IU/L
Change in ovarian 17-hydroxyprogesterone to r-hCG
Time frame · baseline, and 24 hours after receiving rhCG
Registry description
ng/mL
Change in adrenal 17-hydroxyprogesterone to ACTH
Time frame · baseline, 30 minutes, and 60 minutes after ACTH
Registry description
ng/mL
Mean insulin level during oral glucose tolerance test
Time frame · during 2 hours of oral glucose tolerance test
Registry description
uIU/mL
Secondary outcomes(6)
Matsuda index
Time frame · during 2 hours of glucose tolerance test
Registry description
It is an index calculated by using glucose and insulin levels
LH pulse frequency
Time frame · overnight frequent blood sampling (every 10 minutes for 12 hours)
Registry description
pulses/hour
Change in dehydroepiandrosterone (DHEA) to r-hCG
Time frame · baseline, and 24 hours after r-hCG
Registry description
ng/mL
Change in DHEA to ACTH
Time frame · baseline, 30 minutes and 1 hour after ACTH
Registry description
ng/mL
Change in androstenedione to r-hCG
Time frame · baseline, and 24 hours after r-hCG
Registry description
ng/mL
Change in androstenedione to ACTH
Time frame · baseline, 30 minutes and 1 hour after ACTH
Registry description
ng/mL
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 20 Years up to 49 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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