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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
Sponsor:
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 Polycystic Ovary Syndrome
Intervention Drug: recombinant human chorionic gonadotropin
Enrollment 25
Recruitment Details Subjects recruited from UCSD clinics and coal advertising beginning in 2009 and ending in 2010
Pre-assignment Details Subjects involved women with PCOS and normal control women undergoing hCG stimulation
Arm/Group Title PCOS Normal
Hide Arm/Group Description Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions. Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
Period Title: Overall Study
Started 13 12
Completed 10 11
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             3             1
Arm/Group Title PCOS Normal Total
Hide Arm/Group Description Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions. Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions. Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
12
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
28.5  (1.1) 30  (1.3) 29  (1.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
13
 100.0%
12
 100.0%
25
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 12 participants 25 participants
13 12 25
1.Primary Outcome
Title Serum 17OHP Responses to hCG
Hide Description Assess serum 17OHP levels following each dose of hCG adminstration in PCOS and normal subjects
Time Frame 24 hrs post dose
Hide Outcome Measure Data
Hide Analysis Population Description
PCOS and Normal groups were analyzed according to peak 17OHP levels at each dose of r-hCG.
Arm/Group Title PCOS Normal
Hide Arm/Group Description:
Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
Overall Number of Participants Analyzed 10 11
Mean (Standard Error)
Unit of Measure: ng/ml
17OHP post 10 micrograms 2.0  (0.3) 1.2  (0.1)
17OHP level post 1 micrograms 1.1  (0.1) 1.0  (0.1)
17OHP level post 25 micrograms 2.7  (0.3) 1.7  (0.2)
17OHP level post 100 micrograms 3.3  (0.6) 2.2  (0.3)
17OHP level post 250 micrograms 4.0  (0.6) 2.1  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PCOS, Normal
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Serum Testosterone Responses to hCG
Hide 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
Time Frame -0.5, 0, 24 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PCOS Normal
Hide Arm/Group Description:
Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
Each subject received a dose (1, 10, 25, 100, or 250 micrograms) of iv hCG.
Overall Number of Participants Analyzed 10 11
Mean (Standard Error)
Unit of Measure: ng/ml
0.6  (0.1) 0.3  (0.05)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PCOS Normal
Hide Arm/Group Description Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions. Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of hCG administered intravenously on 5 separate occasions.
All-Cause Mortality
PCOS Normal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
PCOS Normal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PCOS Normal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: R. Jeffrey Chang, M.D.
Organization: UCSD School of Medicine
Phone: 858-534-8930
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Chang, MD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00747617     History of Changes
Other Study ID Numbers: 060679
First Submitted: September 4, 2008
First Posted: September 5, 2008
Results First Submitted: August 4, 2011
Results First Posted: January 29, 2013
Last Update Posted: November 21, 2018