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Trial record 81 of 1543 for:    Androgens

Ovarian Morphology and Theca Cell Androgen Production in Women With Polycystic Ovary Syndrome (PCOS)

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ClinicalTrials.gov Identifier: NCT02145247
Recruitment Status : Completed
First Posted : May 22, 2014
Results First Posted : August 12, 2019
Last Update Posted : August 12, 2019
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: hCG
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Adult Women Women With PCOS
Hide Arm/Group Description
  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

Period Title: Overall Study
Started 20 19
Completed 20 19
Not Completed 0 0
Arm/Group Title Normal Adult Women Women With PCOS Total
Hide Arm/Group Description
  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 19 participants 39 participants
26.9
(19 to 34)
26.3
(19 to 37)
26.6
(19 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
20
 100.0%
19
 100.0%
39
 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
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 19 participants 39 participants
20 19 39
Sex and gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
20
 100.0%
19
 100.0%
39
 100.0%
1.Primary Outcome
Title Percent Change of 17-OHP Levels From Baseline
Hide Description

On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

Blood samples will be obtained before and after r-hCG adminstration

Time Frame before and 24 hours after adminisration of r-hCG
Hide Outcome Measure Data
Hide Analysis Population Description
Normal adult women and adult women with PCOS
Arm/Group Title Normal Adult Women Women With PCOS
Hide Arm/Group Description:
  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

Overall Number of Participants Analyzed 20 19
Mean (Standard Error)
Unit of Measure: percent change
67  (10) 140  (26)
Time Frame 1 year
Adverse Event Reporting Description There were no untoward or unfavorable medical occurrences in participating subjects.
 
Arm/Group Title Normal Adult Women Women With PCOS
Hide Arm/Group Description
  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

  1. Images of the both ovaries will be obtained using vaginal ultrasound and the number, size, and spatial arrangement of ovarian follicles will be noted for both ovaries in each subject.
  2. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
  3. Blood samples will be obtained at T = -0.5, 0, and +24 hours.
  4. Blood sample will be used for DNA testing to identify genes that may be associated with androgen production.
  5. One to two weeks after hCG stimulation testing each subject will come to the CTRI for an Oral Glucose Tolerance Test (OGTT). Each subject will ingest 75 gm of a glucose solution and blood samples will be obtained at 0, 15, 30, 60, 120 and 180 minutes after the glucose load.

hCG: 3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.

4. Blood samples will be obtained at T = -0.5, 0, and +24 hours.

All-Cause Mortality
Normal Adult Women Women With PCOS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Normal Adult Women Women With PCOS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Normal Adult Women Women With PCOS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
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: R. Jeffrey Chang
Organization: UCSDMED
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: NCT02145247     History of Changes
Other Study ID Numbers: UCSD-140260
First Submitted: May 20, 2014
First Posted: May 22, 2014
Results First Submitted: March 28, 2019
Results First Posted: August 12, 2019
Last Update Posted: August 12, 2019