Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01154192 |
Recruitment Status :
Completed
First Posted : June 30, 2010
Results First Posted : April 23, 2019
Last Update Posted : April 30, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
PCOS | Drug: Dexamethasone Drug: recombinant human chorionic gonadotropin (r-hCG) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS) |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | September 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: PCOS group
Intervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
|
Drug: Dexamethasone
Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Other Name: recombinant human chorionic gonadotropin (r-hCG) Drug: recombinant human chorionic gonadotropin (r-hCG) Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Other Name: Ovidrel |
Experimental: Normal group
Intervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
|
Drug: Dexamethasone
Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Other Name: recombinant human chorionic gonadotropin (r-hCG) Drug: recombinant human chorionic gonadotropin (r-hCG) Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Other Name: Ovidrel |
Experimental: Oligomenorrhea group
Intervention: Each subject in the Oligomenorrhea group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
|
Drug: Dexamethasone
Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Other Name: recombinant human chorionic gonadotropin (r-hCG) Drug: recombinant human chorionic gonadotropin (r-hCG) Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Other Name: Ovidrel |
- 17OHP Levels After hCG [ Time Frame: 24 hours ]Assess serum levels of 17OHP after stimulation with recombinant hCG
- Testosterone [ Time Frame: 24 hours ]Assess seruim levels of testosterone after stimulation with recombinant hCG
- Androstenedione [ Time Frame: 24 hours ]Assess serum levels of androstenedione after stimaultion with recombinant hCG
- DHEA [ Time Frame: 24 hours ]Assess serum levels of DHEA after stimulation with recombinant hCG

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 18 Years (Child, 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:
- Pregnancy
- On oral contraceptives
- On insulin lowering drugs
- On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- On medications that will influence androgen metabolism or clearance
- On medications that will inhibit the cytochrome P450 enzyme system (Cimetidine, ketoconazole, etc)

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): NCT01154192
United States, California | |
UCSD School of Medicine | |
La Jolla, California, United States, 92093 |
Principal Investigator: | R. Jeffery Chang, M.D. | UCSD School of Medicine |
Responsible Party: | Jeffrey Chang, MD, Principal Investigator, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT01154192 |
Other Study ID Numbers: |
081696 |
First Posted: | June 30, 2010 Key Record Dates |
Results First Posted: | April 23, 2019 |
Last Update Posted: | April 30, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
PCOS oligomenorrhea irregular menses hyperandrogenemia elevated testosterone |
adolescents androgens ovary LH |
Polycystic Ovary Syndrome Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Dexamethasone Chorionic Gonadotropin Anti-Inflammatory Agents |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Reproductive Control Agents |