Trial Outcomes & Findings for Ovarian Morphology and Theca Cell Androgen Production in Women With Polycystic Ovary Syndrome (PCOS) (NCT NCT02145247)
NCT ID: NCT02145247
Last Updated: 2019-08-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
before and 24 hours after adminisration of r-hCG
Results posted on
2019-08-12
Participant Flow
Participant milestones
| Measure |
Normal Adult Women
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.
|
Women With PCOS
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 Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Normal Adult Women
n=20 Participants
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.
|
Women With PCOS
n=19 Participants
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
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.9 years
n=20 Participants
|
26.3 years
n=19 Participants
|
26.6 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
19 Participants
n=19 Participants
|
39 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=39 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
19 participants
n=19 Participants
|
39 participants
n=39 Participants
|
|
Sex and gender
|
20 Participants
n=20 Participants
|
19 Participants
n=19 Participants
|
39 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: before and 24 hours after adminisration of r-hCGPopulation: Normal adult women and adult women with PCOS
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
Outcome measures
| Measure |
Normal Adult Women
n=20 Participants
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.
|
Women With PCOS
n=19 Participants
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.
|
|---|---|---|
|
Percent Change of 17-OHP Levels From Baseline
|
67 percent change
Standard Error 10
|
140 percent change
Standard Error 26
|
Adverse Events
Normal Adult Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women With PCOS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place