Clinical trial · Interventional
Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
Theca Cell Function in Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human chorionic gonadotropin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PCOS group
- description
- Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.
- interventionNames
- Drug: recombinant human chorionic gonadotropin
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.
- interventionNames
- Drug: recombinant human chorionic gonadotropin
Primary outcomes (1)
- measure
- Serum 17OHP Responses to hCG
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDChang RJ. The reproductive phenotype in polycystic ovary syndrome. Nat Clin Pract Endocrinol Metab. 2007 Oct;3(10):688-95. doi: 10.1038/ncpendmet0637. PMID 17893687
- BACKGROUNDWachs DS, Coffler MS, Malcom PJ, Shimasaki S, Chang RJ. Increased androgen response to follicle-stimulating hormone administration in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 May;93(5):1827-33. doi: 10.1210/jc.2007-2664. Epub 2008 Feb 19. PMID 18285408
- BACKGROUNDWachs DS, Coffler MS, Malcom PJ, Chang RJ. Comparison of follicle-stimulating-hormone-stimulated dimeric inhibin and estradiol responses as indicators of granulosa cell function in polycystic ovary syndrome and normal women. J Clin Endocrinol Metab. 2006 Aug;91(8):2920-5. doi: 10.1210/jc.2006-0442. Epub 2006 May 23. PMID 16720653
- BACKGROUNDMehta RV, Malcom PJ, Chang RJ. The effect of androgen blockade on granulosa cell estradiol production after follicle-stimulating hormone stimulation in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Sep;91(9):3503-6. doi: 10.1210/jc.2006-0752. Epub 2006 Jun 27. PMID 16804036
- BACKGROUNDMehta RV, Patel KS, Coffler MS, Dahan MH, Yoo RY, Archer JS, Malcom PJ, Chang RJ. Luteinizing hormone secretion is not influenced by insulin infusion in women with polycystic ovary syndrome despite improved insulin sensitivity during pioglitazone treatment. J Clin Endocrinol Metab. 2005 Apr;90(4):2136-41. doi: 10.1210/jc.2004-1040. Epub 2005 Jan 11. PMID 15644405
- BACKGROUNDChang RJ. A practical approach to the diagnosis of polycystic ovary syndrome. Am J Obstet Gynecol. 2004 Sep;191(3):713-7. doi: 10.1016/j.ajog.2004.04.045. PMID 15467530
- 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.