Polycystic Ovary SyndromeNCT00989781
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
A study testing 3-D Ultrasound, recombinant human chorionic gonadotropin and Recombinant human follicle stimulating hormone in people with Polycystic Ovary Syndrome, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- 3-D Ultrasound, recombinant human chorionic gonadotropin and Recombinant human follicle stimulating hormone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
The first part of this study looks specifically at the structure of the ovaries, which are the female sex glands where both androgens and estrogens (female hormones) are made. It involves imaging your ovaries with a technology called 3-D Ultrasound. We are interested in recording the number, size and arrangement of the follicles in your ovaries.
The second part of the study looks at how the ovary produces male hormones, or androgens, with and without follicle stimulating hormone (FSH) stimulation. Hormones are substances made by a gland in one part of the body which regulate another part. FSH is a hormone naturally produced by the pituitary gland located in the brain and it helps the ovary produce estrogens, or female hormones. LH is a hormone also naturally produced by the pituitary gland and it has the ability to stimulate the ovary to make androgens. We are interested to see how much androgen your ovaries will produce in response to LH with and without FSH. To accomplish this, you will be given FSH as well as hCG, a drug that acts like LH to stimulate the ovary; FSH and hCG are approved by the Food and Drug Administration (FDA) for this investigational, off-label use.
The third part of the study looks at how much the adrenal glands contribute to the increase male hormone levels seen in PCOS. ACTH is a hormone naturally produced by the pituitary gland located in the brain and it stimulates the adrenals to make hormones. The adrenal glands are above the kidneys. They are chiefly responsible for helping the body adjust to stressful situations and work by producing cortisol and adrenaline. The adrenal glands also produce androgens, or male hormones. Previous studies have shown that some women with PCOS produce more male hormones from their adrenals. We are interested to see how much androgen your adrenal glands produce. To accomplish this, you will first be given dexamethasone, a stress steroid, to temporarily suppress your adrenal glands. You will then be given ACTH intravenously over the course of 7 hours to stimulate your adrenal glands.
The fourth part of the study is for PCOS women only and looks at how much the role of insulin contributes to the increase male hormone levels. Insulin is a hormone naturally produced by the pancreas that stimulates all of the cells in your body to take up glucose, or sugar, from the blood. Previous studies have shown that PCOS women who are more resistant to insulin, or whose cells do not take up glucose from the blood in response to insulin, make more male hormones. We are interested to see how much androgen your ovaries produce in response to LH before and after we temporarily decrease the amount of insulin in your blood. To accomplish this, you will again be given hCG, a drug that acts like LH to stimulate the ovary, with and without diazoxide, a drug that decreases the amount of insulin in your bloodstream. These tests will all be done after you are on a diet that limits how much sugar you eat. To test how much insulin you make, you will also be given Oral Glucose Tolerance Tests before and after diazoxide. This test is done by drinking a sugary liquid and testing your blood over 3 hours.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- 3-D Ultrasound, recombinant human chorionic gonadotropin, Recombinant human follicle stimulating hormone, Adrenocorticotropin, Dexamethasone
- Keywords
- PCOS, Androgens, ovary, polycystic
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D UltrasoundRadiation
One time pelvic ultrasound
recombinant human chorionic gonadotropinDrug
Also called Ovidrel, r-hCG
Recombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards
Recombinant human follicle stimulating hormoneDrug
Also called Gonal-F, r-hFSH
Recombinant human follicle stimulating hormone will be given iv and blood samples obtained before and 24 hr later.
AdrenocorticotropinDrug
Also called Cosyntropin, ACTH
Each subject will receive a 7 hr dose-response infusion of Adrenocorticotropin.
DexamethasoneDrug
Also called corticosteroid
Dexamethasone will be given prior to ACTH infusion test.
GlucoseDrug
Also called sugar
Each subject will undergo 3 oral glcuose tolerance tests.
| Study group | Role | What they receive |
|---|---|---|
| PCOS women | Experimental | 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. Receives: Radiation: 3-D Ultrasound; Drug: recombinant human chorionic gonadotropin; Drug: Recombinant human follicle stimulating hormone; Drug: Adrenocorticotropin; Drug: Dexamethasone; Drug: Glucose |
| Normal women | Experimental | 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. Receives: Radiation: 3-D Ultrasound; Drug: recombinant human chorionic gonadotropin; Drug: Recombinant human follicle stimulating hormone; Drug: Adrenocorticotropin; Drug: Dexamethasone; Drug: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection
Measured: Baseline and 24 hours after hCG
Secondary outcomes (3)
Adrenal 17-hydroxyprogesterone Response to ACTH in PCOS Women and Normal Controls
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.
Measured: Baseline and 1, 2, 3, 4, 5, and 6 hours after ACTH
17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
17 hydroxyprogesterone levels
Measured: Baseline and 24 after hCG
Anti-Mullerian Hormone (AMH)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Chang, MD, University of California, San Diego
- Investigators
- R. Jeffrey Chang, M.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989781
- Sponsor's protocol ID
- 090560
- Status last verified
- May 2018
- First submitted
- 5 Oct 2009
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00989781
- Acronym / sponsor ID
- 090560
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Androgens, ovary, polycystic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 6 Oct 2009 (estimated)
- Results
- Posted 17 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The first part of this study looks specifically at the structure of the ovaries, which are the female sex glands where both androgens and estrogens (female hormones) are made. It involves imaging your ovaries with a technology called 3-D Ultrasound. We are interested in recording the number, size and arrangement of the follicles in your ovaries.
The second part of the study looks at how the ovary produces male hormones, or androgens, with and without follicle stimulating hormone (FSH) stimulation. Hormones are substances made by a gland in one part of the body which regulate another part. FSH is a hormone naturally produced by the pituitary gland located in the brain and it helps the ovary produce estrogens, or female hormones. LH is a hormone also naturally produced by the pituitary gland and it has the ability to stimulate the ovary to make androgens. We are interested to see how much androgen your ovaries will produce in response to LH with and without FSH. To accomplish this, you will be given FSH as well as hCG, a drug that acts like LH to stimulate the ovary; FSH and hCG are approved by the Food and Drug Administration (FDA) for this investigational, off-label use.
The third part of the study looks at how much the adrenal glands contribute to the increase male hormone levels seen in PCOS. ACTH is a hormone naturally produced by the pituitary gland located in the brain and it stimulates the adrenals to make hormones. The adrenal glands are above the kidneys. They are chiefly responsible for helping the body adjust to stressful situations and work by producing cortisol and adrenaline. The adrenal glands also produce androgens, or male hormones. Previous studies have shown that some women with PCOS produce more male hormones from their adrenals. We are interested to see how much androgen your adrenal glands produce. To accomplish this, you will first be given dexamethasone, a stress steroid, to temporarily suppress your adrenal glands. You will then be given ACTH intravenously over the course of 7 hours to stimulate your adrenal glands.
The fourth part of the study is for PCOS women only and looks at how much the role of insulin contributes to the increase male hormone levels. Insulin is a hormone naturally produced by the pancreas that stimulates all of the cells in your body to take up glucose, or sugar, from the blood. Previous studies have shown that PCOS women who are more resistant to insulin, or whose cells do not take up glucose from the blood in response to insulin, make more male hormones. We are interested to see how much androgen your ovaries produce in response to LH before and after we temporarily decrease the amount of insulin in your blood. To accomplish this, you will again be given hCG, a drug that acts like LH to stimulate the ovary, with and without diazoxide, a drug that decreases the amount of insulin in your bloodstream. These tests will all be done after you are on a diet that limits how much sugar you eat. To test how much insulin you make, you will also be given Oral Glucose Tolerance Tests before and after diazoxide. This test is done by drinking a sugary liquid and testing your blood over 3 hours.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS women | Experimental | Radiation: 3-D Ultrasound, Drug: recombinant human chorionic gonadotropin, Drug: Recombinant human follicle stimulating hormone, Drug: Adrenocorticotropin, Drug: Dexamethasone, Drug: GlucoseEach 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 | Experimental | Radiation: 3-D Ultrasound, Drug: recombinant human chorionic gonadotropin, Drug: Recombinant human follicle stimulating hormone, Drug: Adrenocorticotropin, Drug: Dexamethasone, Drug: GlucoseEach 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. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-D UltrasoundOne time pelvic ultrasound | Radiation | Normal women, PCOS women |
| recombinant human chorionic gonadotropinAlso: Ovidrel, r-hCGRecombinant human chorionic gonadotropin will be given iv and blood samples obtained before and 24 hr afterwards | Drug | Normal women, PCOS women |
| Recombinant human follicle stimulating hormoneAlso: Gonal-F, r-hFSHRecombinant human follicle stimulating hormone will be given iv and blood samples obtained before and 24 hr later. | Drug | Normal women, PCOS women |
| AdrenocorticotropinAlso: Cosyntropin, ACTHEach subject will receive a 7 hr dose-response infusion of Adrenocorticotropin. | Drug | Normal women, PCOS women |
| DexamethasoneAlso: corticosteroidDexamethasone will be given prior to ACTH infusion test. | Drug | Normal women, PCOS women |
| GlucoseAlso: sugarEach subject will undergo 3 oral glcuose tolerance tests. | Drug | Normal women, PCOS women |
Primary outcome
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls
Time frame: Baseline and 24 hours after hCG
Change from baseline in 17-hydroxyprogesterone at 24 hours after hCG injection
3 secondary outcomes
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
17 Hydroxyprogesterone Response to hCG Injection After Lowered Insulin Levels.
Time frame: Baseline and 24 after hCG
Anti-Mullerian Hormone (AMH)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Jeffrey Chang, M.D. principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D Ultrasound, recombinant human chorionic gonadotropin and Recombinant human follicle stimulating hormone in people with Polycystic Ovary Syndrome, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls (time frame: Baseline and 24 hours after hCG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.