Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)
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ClinicalTrials.gov Identifier: NCT00747617 |
Recruitment Status :
Completed
First Posted : September 5, 2008
Results First Posted : January 29, 2013
Last Update Posted : November 21, 2018
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Drug: recombinant human chorionic gonadotropin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Theca Cell Function in Women With Polycystic Ovary Syndrome |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: recombinant human chorionic gonadotropin
Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Other Name: Ovidrel |
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.
|
Drug: recombinant human chorionic gonadotropin
Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.
Other Name: Ovidrel |
- Serum 17OHP Responses to hCG [ Time Frame: 24 hrs post dose ]Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects
- Serum Testosterone Responses to hCG [ Time Frame: -0.5, 0, 24 hrs ]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

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747617
United States, California | |
University of California, San Diego, School of Medicine | |
La Jolla, California, United States, 92093 |
Principal Investigator: | R, Jeffrey Chang, M.D. | UCSD SChool of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jeffrey Chang, MD, Principal investigator, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00747617 |
Other Study ID Numbers: |
060679 |
First Posted: | September 5, 2008 Key Record Dates |
Results First Posted: | January 29, 2013 |
Last Update Posted: | November 21, 2018 |
Last Verified: | October 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
polycystic ovary syndrome androgens ovary LH |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms |
Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Chorionic Gonadotropin Reproductive Control Agents Physiological Effects of Drugs |