Primary outcomeMean· Baseline and 24 hours after hCG
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
| Group | Value (ng/ml) | Spread |
|---|---|---|
| NR-PCOS Women | 1.3 | 0.2 |
| HR-PCOS Women | 3 | 1 |
| Normal Women | 1.1 | 0.2 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataMechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
NCTNCT00989781 (opens ClinicalTrials.gov in a new tab)Other id090560
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 41 participants (actual)
- Sponsor
- University of California, San Diego · Other
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Sept 2009
- Primary completion
- Sept 2013
- Completion
- Sept 2013
- First posted
- 6 Oct 2009 (estimated)
- Last update posted
- 4 Jun 2018
- Conditions
- Polycystic Ovary Syndrome
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200920102011201220132014
- N/A
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
NCT00989781Sept 2009 to Sept 2013
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Jeffrey Chang MD is conducting a research study to learn more about the increased male hormone levels, otherwise known as androgens, seen in women with polycystic ovary syndrome (PCOS). Women with PCOS have ovaries that are comprised of many cysts, or follicles. They also have irregular or absent menstrual periods and symptoms of increased male hormones, such as facial hair or acne. In each part of the study (except part 4 which is for PCOS women only) we will be comparing responses of PCOS women to normal controls
Interventions
- 3-D UltrasoundRadiation
- recombinant human chorionic gonadotropinDrug
- Recombinant human follicle stimulating hormoneDrug
- AdrenocorticotropinDrug
- DexamethasoneDrug
- GlucoseDrug
Arms2
Experimental
PCOS women
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.
Experimental
Normal women
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
Time frame · Baseline and 24 hours after hCG
Registry description
Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection
Secondary outcomes(3)
Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
Time frame · Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH
Registry description
17-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.
17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
Time frame · Baseline and 24 after hCG
Registry description
17 hydroxyprogesterone levels
Anti-Mullerian Hormone (AMH)
Time frame · Baseline
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH
Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
| Group | Value (ng/ml) | Spread |
|---|---|---|
| NR-PCOS Women | 6.0 | 0.8 |
| HR-PCOS Women | 8.1 | 0.4 |
| Normal Women | 6.2 | 0.4 |
Secondary outcomeCount of participants· Baseline and 24 after hCG
17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
| Group | Value (Participants) |
|---|---|
| NR-PCOS Women | 0 |
| HR-PCOS Women | 0 |
| Normal Women | 0 |
Secondary outcomeMean· Baseline
Anti-Mullerian Hormone (AMH)
| Group | Value (ng/ml) | Spread |
|---|---|---|
| NR-PCOS Women | 16.0 | 1.5 |
| HR-PCOS Women | 6.7 | 1.5 |
| Normal Women | 5.3 | 1.0 |
Other pre specified outcomeMean· baseline
Follicle Count on 3-D Ultrasound in PCOS Women and Normal Controls
| Group | Value (Antral Follicle Count) | Spread |
|---|---|---|
| NR-PCOS Women | 64.4 | 9.5 |
| HR-PCOS Women | 49.3 | 5.6 |
| Normal Women | 31.8 | 3.4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PCOS WomenEach subject will undergo pelvic 3D ultrasound and an iv recombinant human chorionic gonadotropin (r-hCG) stimulation test. One month later 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 before 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, the r-hCG stimulation test and OGTT will be repeated as described above. 3-D Ultrasound: One time pelvic ultrasound recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards Recombinant human follicle stimulating | – | 0 / 21 | 0 / 21 |
| Normal WomenEach subject will undergo pelvic 3D ultrasound and 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, the r-hCG stimulation test and OGTT will be repeated as described above. 3-D Ultrasound: One time pelvic ultrasound recombinant human chorionic gonadotropin: Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards Recombinant human follicle stimulati | – | 0 / 20 | 0 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 37 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
A group of 40 women with PCOS and 20 normal women ages 18-37 will be studied.
* Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound.
* Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start.
* Subjects will be determined to be normal controls if they have a clinical history of regular periods
Exclusion Criteria:
* Women with hemoglobin less than 11 gm/dl at screening evaluation
* Women with untreated thyroid abnormalities
* Pregnant women or women who are nursing
* Women with BMI \> 37
* Women with known sensitivity to the agents being used
* Women with prosthetic devices (i.e.,ear)/ shunts (ventricular), Hearing aids, Metal plate/pins/screws/wires
* Women with diabetes, or renal, liver, or heart disease.
PepBank is a research reference. Talk to a doctor before you use any peptide.