Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
University of Virginia
Information provided by (Responsible Party):
Jeffrey Chang, MD, University of California, San Diego

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition PCOS
Interventions Drug: Dexamethasone
Drug: recombinant human chorionic gonadotropin (r-hCG)
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PCOS Group Normal Group There Were Only 2 Groups: PCOS and Normal Subjects
Hide Arm/Group Description

Intervention: Each subject in the PCOS 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.

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.

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

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.

Dexamethasone

[Not Specified]
Period Title: Overall Study
Started 14 10 0
Completed 14 10 0
Not Completed 0 0 0
Arm/Group Title PCOS Group Normal Group Oligomenorrhea Group Total
Hide Arm/Group Description 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. 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. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 14 10 0 24
Hide Baseline Analysis Population Description
Oligpomenorrhea subjects not part of study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 10 participants 0 participants 24 participants
14.9  (1.0) 15.4  (1.2) 15.3  (1.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 10 participants 0 participants 24 participants
Female
14
 100.0%
10
 100.0%
24
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title 17OHP Levels After hCG
Hide Description Assess serum levels of 17OHP after stimulation with recombinant hCG
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Oligmenorhea group not included in study
Arm/Group Title PCOS Group Normal Group Oligomenorrhea Group
Hide Arm/Group Description:
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 14 10 0
Mean (Standard Error)
Unit of Measure: ng/ml
3.2  (0.5) 1.3  (0.3)
2.Secondary Outcome
Title Testosterone
Hide Description Assess seruim levels of testosterone after stimulation with recombinant hCG
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Oligpmenrreha group not included in study
Arm/Group Title PCOS Group Normal Group Oligomenorrhea Group
Hide Arm/Group Description:
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.

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.

.

[Not Specified]
Overall Number of Participants Analyzed 14 10 0
Mean (Standard Error)
Unit of Measure: ng/ml
1.6  (0.2) 1.0  (0.2)
3.Secondary Outcome
Title Androstenedione
Hide Description Assess serum levels of androstenedione after stimaultion with recombinant hCG
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Oligomenorreha group not inlcuded in study
Arm/Group Title PCOS Group Normal Group Oligomenorrhea Group
Hide Arm/Group Description:
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 14 10 0
Mean (Standard Error)
Unit of Measure: ng/ml
2.1  (0.2) 0.9  (0.2)
4.Secondary Outcome
Title DHEA
Hide Description Assess serum levels of DHEA after stimulation with recombinant hCG
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Oligomenrrhea group not included in study
Arm/Group Title PCOS Group Normal Group Oligomenorrhea Group
Hide Arm/Group Description:
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.
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.
[Not Specified]
Overall Number of Participants Analyzed 14 10 0
Mean (Standard Error)
Unit of Measure: ng/ml
1.6  (0.2) 1.0  (0.2)
Time Frame 1 year
Adverse Event Reporting Description The number of participants at risk for Other Adverse Events, All-Cause Mortality, and Serious Adverse Events should be 24
 
Arm/Group Title PCOS Group Normal Group Oligomenorrhea Group
Hide Arm/Group Description 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. 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. Not included in the study
All-Cause Mortality
PCOS Group Normal Group Oligomenorrhea Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/10 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
PCOS Group Normal Group Oligomenorrhea Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/10 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PCOS Group Normal Group Oligomenorrhea Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/10 (0.00%)   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. R. Jeffrey Chang
Organization: UC San Diego School of Medicine
Phone: 858-534-8930
EMail: rjchang@ucsd.edu
Layout table for additonal information
Responsible Party: Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01154192     History of Changes
Other Study ID Numbers: 081696
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: March 29, 2019
Results First Posted: April 23, 2019
Last Update Posted: April 30, 2019