Trial · Interventional

CompletedPhase 3Results postedRegistry data

Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)

NCTNCT00747617Other id060679

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 25 participants (actual)
Sponsor: University of California, San Diego · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Sept 2007
Primary completion: Apr 2010
Completion: Sept 2010
First posted: 5 Sept 2008 (estimated)
Last update posted: 21 Nov 2018
Conditions: Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20072008200920102011

Ph 3
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
NCT00747617
Sept 2007 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.

Interventions

recombinant human chorionic gonadotropinDrug

Arms2

Active comparator
PCOS group
Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.
Active comparator
Control group
Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.

Primary outcomes1

Outcomes the sponsor listed as primary.

Serum 17OHP Responses to hCG
Time frame · 24 hrs post dose
Registry description
Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects

Secondary outcomes(1)

Serum Testosterone Responses to hCG
Time frame · -0.5, 0, 24 hrs
Registry description
Mean serum testosterone levels before and after hCG injection. Serum testosterone levels before (-0.5 and 0 hrs) were averaged to achieve a single value

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 24 hrs post dose

Serum 17OHP Responses to hCG

Group	Value (ng/ml)	Spread
PCOS	2.0	0.3
Normal	1.2	0.1

Secondary and other outcome results(1)

Secondary outcomeMean· -0.5, 0, 24 hrs

Serum Testosterone Responses to hCG

Group	Value (ng/ml)	Spread
PCOS	0.6	0.1
Normal	0.3	0.05

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PCOSEach subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	0 / 13	0 / 13	0 / 13
NormalEach subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.	0 / 12	0 / 12	0 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

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.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMaas KH, Chuan S, Harrison E, Cook-Andersen H, Duleba AJ, Chang RJ. Androgen responses to adrenocorticotropic hormone infusion among individual women with polycystic ovary syndrome. Fertil Steril. 2016 Oct;106(5):1252-1257. doi: 10.1016/j.fertnstert.2016.06.039. Epub 2016 Jul 26. PMID 27473350
DerivedMaas KH, Chuan SS, Cook-Andersen H, Su HI, Duleba A, Chang RJ. Relationship between 17-hydroxyprogesterone responses to human chorionic gonadotropin and markers of ovarian follicle morphology in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2015 Jan;100(1):293-300. doi: 10.1210/jc.2014-2956. PMID 25313914
DerivedCook-Andersen H, Chuan SS, Maas K, Rosencrantz MA, Su HI, Lawson M, Mason HD, Chang RJ. Lack of Serum anti-Mullerian hormone responses after recombinant human chorionic gonadotropin stimulation in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2015 Jan;100(1):251-7. doi: 10.1210/jc.2014-2948. PMID 25303490
DerivedShayya RF, Rosencrantz MA, Chuan SS, Cook-Andersen H, Roudebush WE, Irene Su H, Shimasaki S, Chang RJ. Decreased inhibin B responses following recombinant human chorionic gonadotropin administration in normal women and women with polycystic ovary syndrome. Fertil Steril. 2014 Jan;101(1):275-9. doi: 10.1016/j.fertnstert.2013.09.037. Epub 2013 Nov 1. PMID 24188875
DerivedRosencrantz MA, Coffler MS, Haggan A, Duke KB, Donohue MC, Shayya RF, Su HI, Chang RJ. Clinical evidence for predominance of delta-5 steroid production in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2011 Apr;96(4):1106-13. doi: 10.1210/jc.2010-2200. Epub 2011 Jan 26. PMID 21270326

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 35 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Normal CBC (Hemoglobin must be at least 11mg/dl) * Normal renal and liver function tests * Normal vital signs including normal blood pressure Exclusion Criteria: * No oral contraceptives * No insulin lowering drugs * No anti-androgens (i.e., spironolactone, flutamide, finasteride, etc) * No medications that will influence androgen metabolism or clearance * No medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconozole, etc) * No use of clomiphene citrate within 3 months prior to study

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