NCT03905603

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

6.5 years

First QC Date

April 2, 2019

Last Update Submit

November 1, 2023

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (5)

  • Change in calculated free testosterone concentrations

    pg/mL

    baseline, 30 mininutes and 1 hour after adrenocorticotropic hormone (ACTH), 24 hours after recombinant human chorionic gonadotropin (rhCG).

  • Mean luteinizing hormone (LH) concentrations

    IU/L

    overnight frequent blood sampling (every 10 mininutes for 12 hours)

  • Change in ovarian 17-hydroxyprogesterone to r-hCG

    ng/mL

    baseline, and 24 hours after receiving rhCG

  • Change in adrenal 17-hydroxyprogesterone to ACTH

    ng/mL

    baseline, 30 minutes, and 60 minutes after ACTH

  • Mean insulin level during oral glucose tolerance test

    uIU/mL

    during 2 hours of oral glucose tolerance test

Secondary Outcomes (6)

  • Matsuda index

    during 2 hours of glucose tolerance test

  • LH pulse frequency

    overnight frequent blood sampling (every 10 minutes for 12 hours)

  • Change in dehydroepiandrosterone (DHEA) to r-hCG

    baseline, and 24 hours after r-hCG

  • Change in DHEA to ACTH

    baseline, 30 minutes and 1 hour after ACTH

  • Change in androstenedione to r-hCG

    baseline, and 24 hours after r-hCG

  • +1 more secondary outcomes

Study Arms (1)

ACTH (Cosyntropin), rhCG (Ovidrel)

EXPERIMENTAL

ACTH (Cosyntropin) administered 250 mcg IV; rhCG (Ovidrel) administered 250 mcg IV

Drug: ACTHDrug: rhCG

Interventions

ACTHDRUG

ACTH (Cosyntropin) 250 mcg will be given once during the study.

Also known as: Cosyntropin
ACTH (Cosyntropin), rhCG (Ovidrel)
rhCGDRUG

rhCG (Ovidrel) 250 mcg will be given once during the study.

Also known as: Ovidrel
ACTH (Cosyntropin), rhCG (Ovidrel)

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis is a study regarding PCOS, so only females will be eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with PCOS aged 20-30 years and 40-49 years. Subject is considered to have PCOS if she has current or verifiable history of: a) clinical and/or biochemical evidence of hyperandrogenism plus b) oligomenorrhea (average menstrual cycle length \>45 days or fewer than 9 menses/year) or irregular menstruation (substantially inconsistent menstrual cycle length). Note: For subjects aged 40-49 years, they will be allowed to participate if they have fewer than 10 menses/year (average menstrual cycle length \>35 days) as long as they have a compelling past history of oligomenorrhea or irregular menstruation.

You may not qualify if:

  • Subjects must be willing and able to provide written informed consent.
  • Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of the study
  • Willingness and ability to comply with scheduled visits and study procedures
  • Postmenopausal status (i.e., absence of periods for previous year plus elevated follicle stimulating hormone \[FSH\] level)
  • Biochemical evidence for perimenopause as defined by an anti-Mullerian hormone \<0.5 ng/mL. As an alternative, cycle day 3 FSH \> 9 IU/L (with concomitant estradiol level \>80 pg/mL), if this testing is available, will serve as evidence of perimenopause status. NOTE: If FSH \>9 IU/L on screening (but it is not cycle day 3), FSH and estradiol will be repeated on cycle day 3.
  • History of hysterectomy and/or bilateral oophorectomy
  • BMI ≥ 40 kg/m2
  • Inability to comprehend what will be done during the study or why it will be done.
  • Being a study of older women with PCOS, children and men will be excluded.
  • Pregnancy or lactation within the past 6 months. Subjects with a positive pregnancy test will be informed of the result by the screening physician.
  • Prisoners.
  • History of (or clinical evidence for) Cushing's syndrome or adrenal insufficiency.
  • History of congenital adrenal hyperplasia or 17-hydroxyprogesterone (17-OHP) \>200 ng/dL, which suggest the possibility of congenital adrenal hyperplasia. 17-OHP will be collected during follicular phase. NOTE: if a 17-OHP \>200 ng/dL and is confirmed on repeat testing, an ACTH-stimulated 17-OHP \<1000 ng/dL will be required for study participation.
  • Total testosterone \>150 ng/dL, which suggests the possibility of virilizing neoplasm.
  • DHEA-S greater than 1.5 times the upper limit of normal range (mild elevations may be seen in PCOS, so elevations \< 1.5 times the upper limit of normal will be accepted in these groups).
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22901, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Adrenocorticotropic HormoneCosyntropinOvidrel

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • Chris McCartney, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa G Gilrain, BS

CONTACT

434-243-6911pcos@virginia.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
No masking is involved in this study.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This is a cross-sectional physiological observational study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 5, 2019

Study Start

October 8, 2019

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

November 3, 2023

Record last verified: 2023-11

Locations

US(1)