Trial Outcomes & Findings for Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome (NCT NCT00989781)
NCT ID: NCT00989781
Last Updated: 2018-06-04
Results Overview
Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
Baseline and 24 hours after hCG
Results posted on
2018-06-04
Participant Flow
Subjects were recruited from UC San Dego clinics and by advertisement in the community. Recruitment began in the summer of 2011 and was completed in Septemebr 2013. Explanation of the research protocol was done by phone and in person.
41 subjects recruited. 5 dropped out prior to study. Of 36 eligible for adrenal study, 8 dropped out before study,
Participant milestones
| Measure |
PCOS Women
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|
|
Ovarian Response to hCG
STARTED
|
21
|
20
|
|
Ovarian Response to hCG
COMPLETED
|
18
|
18
|
|
Ovarian Response to hCG
NOT COMPLETED
|
3
|
2
|
|
Adrenal Response ot ACTH
STARTED
|
18
|
18
|
|
Adrenal Response ot ACTH
COMPLETED
|
13
|
15
|
|
Adrenal Response ot ACTH
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
PCOS Women
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|
|
Ovarian Response to hCG
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
Baseline characteristics by cohort
| Measure |
PCOS Women
n=21 Participants
Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above.
|
Normal Women
n=20 Participants
Each subject will undergo pelvic 3D ultrasound followed by an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT as described above.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
20 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 hours after hCGChange from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection
Outcome measures
| Measure |
NR-PCOS Women
n=10 Participants
PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
HR-PCOS Women
n=8 Participants
PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
n=18 Participants
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|---|
|
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
|
1.3 ng/ml
Standard Error 0.2
|
3 ng/ml
Standard Error 1
|
1.1 ng/ml
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH17-hydroxyprogesterone response to ACTH infusion in women with PCOS and normal women. Response is reported as a single value generated by summing the data at end time frame.
Outcome measures
| Measure |
NR-PCOS Women
n=6 Participants
PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
HR-PCOS Women
n=7 Participants
PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
n=15 Participants
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|---|
|
Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
|
6.0 ng/ml
Standard Error 0.8
|
8.1 ng/ml
Standard Error 0.4
|
6.2 ng/ml
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline and 24 after hCG17 hydroxyprogesterone levels
Outcome measures
| Measure |
NR-PCOS Women
PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
HR-PCOS Women
n=2 Participants
PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
n=2 Participants
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|---|
|
17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
NR-PCOS Women
n=10 Participants
PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
HR-PCOS Women
n=8 Participants
PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
n=18 Participants
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|---|
|
Anti-Mullerian Hormone (AMH)
|
16.0 ng/ml
Standard Error 1.5
|
6.7 ng/ml
Standard Error 1.5
|
5.3 ng/ml
Standard Error 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline3-D ultrasound was not assessed; instead 2-D ultrasound was performed
Outcome measures
| Measure |
NR-PCOS Women
n=10 Participants
PCOS women with normal 17-OHP responses to hCG are designated as NR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
HR-PCOS Women
n=8 Participants
PCOS women with exaggerated 17-OHP responses to hCG are designated as HR-PCOS. Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
Normal Women
n=18 Participants
Each subject will undergo pelvic ultrasound followed by iv recombinant human chorionic gonadotropin (r-hCG) stimulation. 1 month later the r-hCG test will be repeated 24 hr after an injection of recombinant human follicle stimulating hormone (FSH).
After 1 month, subjects will receive a 7 hr dose-response infusion of adrenocorticotropin (ACTH) with blood sampling. Dexamethasone will be given prior to ACTH.
After 1 month, subject will receive r-hCG as described above followed the next day by an oral glucose tolerance test (OGTT). Subsequently, subjects will take Diazoxide 3 times a day for 2 weeks. At weekly intervals (2 weeks), the r-hCG stimulation test will be repeated followed the next day by an OGTT.
|
|---|---|---|---|
|
Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls
|
64.4 Antral Follicle Count
Standard Error 9.5
|
49.3 Antral Follicle Count
Standard Error 5.6
|
31.8 Antral Follicle Count
Standard Error 3.4
|
Adverse Events
PCOS Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Women
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