Polycystic Ovary SyndromeCBS001NCT01421810
Ovarian Contribution to Androgen Production in Adolescent Girls
A study testing Dexamethasone and rhCG in people with Polycystic Ovary Syndrome and Obesity, run by University of Virginia at 1 site in United States.
Trial summary
Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. Read more about this study
- Who is it for?
- Ages 7 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity, Hyperandrogenism
- What is being tested?
- Dexamethasone and rhCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2011to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Girls age 7-18 years
- Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile)
- With or without signs of excess androgen
- Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Who cannot join
- Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR #12702/JCM022. This protocol is designed to allow subjects enrolling in IRB-HSR #12702/JCM022 to simultaneously participate in this companion protocol.
- Inability to comprehend what will be done during the study or why it will be done
- BMI-for-age < 5th percentile
- Weight < 27 kg if simultaneously participating in IRB-HSR #12702/JCM022 due to blood volume limits
- Obesity associated with a diagnosed genetic syndrome (e.g. Prader-Willi syndrome)
- Since the study involves looking at ovarian function, boys will be excluded.
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- Positive pregnancy test or lactation. Subjects with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors. However, the screening physician will encourage them to tell their parent(s) and counsel them about the importance of appropriate prenatal care and counseling. We will arrange follow-up for them at the Teen Health Clinic at the University of Virginia or their primary care physician's office in a timely manner.
- Abnormal laboratory studies will be confirmed by repeat testing to exclude laboratory error.
- Morning cortisol < 3 microgram/dL or history of Cushing syndrome or adrenal insufficiency
- History of congenital adrenal hyperplasia or 17-hydroxyprogesterone > 300 ng/dL, which suggests the possibility of congenital adrenal hyperplasia (if postmenarchal, the 17-hydroxyprogesterone will be collected during the follicular phase, or ≥ 40 days since last menses if oligomenorrheic). NOTE: If a 17-hydroxyprogesterone >300 mg/dL is confirmed on repeat testing, an adrenocorticotropic hormone-stimulated 17-hydroxyprogesterone <1000 ng/dL will be required for study participation.
- Total testosterone > 150 ng/dL
- Previous diagnosis of diabetes, fasting glucose ≥126 mg/dL, or a hemoglobin A1c >6.5%
- Abnormal thyroid stimulating hormone (TSH) for age. Subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded.
- Abnormal prolactin. Mild elevations may be seen in overweight girls, and elevations <1.5 times the upper limit of normal will be accepted in this group.
- Persistent hematocrit <36% and hemoglobin <12 g/dL. Subjects with a mildly low hematocrit (33-36%) will be asked to take iron in the form of ferrous gluconate for up to 60 days. Subjects weighing ≤ 36 kg will take one 300-325 mg tablet oral ferrous gluconate daily (containing 36 mg elemental iron); subjects weighing >36 kg will take two 300-325 mg tablets oral ferrous gluconate daily (containing 36 mg elemental iron each). They will return to the Clinical Research Unit (CRU) or alternate UVA clinical unit after 30-60 days of iron therapy to have their hemoglobin or hematocrit rechecked and will proceed with the remainder of the study if it is ≥12 g/dL or ≥36%, respectively.
- Persistent liver test abnormalities, with the exception that mild bilirubin elevations will be accepted in the setting of known Gilbert's syndrome. Mild elevations may be seen in overweight girls, so elevations <1.5 times the upper limit of normal will be accepted in this group.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, 22908
About this study
Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.
Read the detailed description
Adolescent hyperandrogenemia can represent a forerunner to adult PCOS. Because adrenarche leads to an increase in adrenal androgen production during early puberty and since early puberty is associated with an overnight rise in testosterone that follows a similar time course to cortisol, we hypothesize that the adrenal gland is a major source of androgens in early puberty. On the other hand, the overnight rise in testosterone may reflect an ovarian response to overnight increases of gonadotropin secretion in early puberty. However, the ability of the ovaries to produce androgens (e.g., to respond to gonadotropin stimulation) during early puberty has not been tested concurrently in these girls. The sources of excess androgen production and the timing of their relative contributions across puberty are important in understanding the mechanism of hyperandrogenemia in these individuals. In addition, determination of the sources of hyperandrogenemia across puberty may have clinical utility in the development of preclinical screening tests designed to reveal those girls at greatest risk for PCOS and identification of potential therapeutic targets to prevent its development.
- Conditions
- Polycystic Ovary Syndrome, Obesity, Hyperandrogenism
- Being tested
- Dexamethasone, rhCG
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Hyperandrogenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
1 mg PO
rhCGDrug
Also called (Ovidrel)
25 mcg IV
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone, rhCG (Ovidrel) | Experimental | rhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO Receives: Drug: Dexamethasone; Drug: rhCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty
Measured: 24 hours after administration of rhCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study start10 Mar 2011
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego
- Responsible party
- Principal investigator, Christine Burt Solorzano, University of Virginia
- Investigators
- Christine Burt Solorzano, MD, Principal investigator, University of Virginia Center for Research in Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421810
- Sponsor's protocol ID
- 15298
- Acronym
- CBS001
- Status last verified
- Oct 2023
- First submitted
- 17 Aug 2011
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Contribution to Androgen Production in Adolescent Girls
- ClinicalTrials.gov ID
- NCT01421810
- Acronym / sponsor ID
- CBS001 / 15298
- Conditions
- Polycystic Ovary Syndrome, Obesity, Hyperandrogenism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of California, San Diego
- Study start
- 10 Mar 2011 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women with polycystic ovary syndrome (PCOS) can have unwanted facial or male-patterned body hair, irregular menstrual periods, or no menstrual periods excess body weight, and infertility. It also results in elevated androgen levels such as testosterone. In women with PCOS, the majority of excess androgens are produced by the ovaries. However, it is unknown whether the ovaries are fully active during early puberty. The purpose of this study is to determine how the ovaries contribute to the production of male hormones in the body during different stages of puberty, so that it can be better understood why some females have excess androgens.
Detailed description
Adolescent hyperandrogenemia can represent a forerunner to adult PCOS. Because adrenarche leads to an increase in adrenal androgen production during early puberty and since early puberty is associated with an overnight rise in testosterone that follows a similar time course to cortisol, we hypothesize that the adrenal gland is a major source of androgens in early puberty. On the other hand, the overnight rise in testosterone may reflect an ovarian response to overnight increases of gonadotropin secretion in early puberty. However, the ability of the ovaries to produce androgens (e.g., to respond to gonadotropin stimulation) during early puberty has not been tested concurrently in these girls. The sources of excess androgen production and the timing of their relative contributions across puberty are important in understanding the mechanism of hyperandrogenemia in these individuals. In addition, determination of the sources of hyperandrogenemia across puberty may have clinical utility in the development of preclinical screening tests designed to reveal those girls at greatest risk for PCOS and identification of potential therapeutic targets to prevent its development.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexamethasone, rhCG (Ovidrel) | Experimental | Drug: Dexamethasone, Drug: rhCGrhCG (Ovidrel) administered 25 mcg IV; dexamethasone administered 1 mg PO |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Girls age 7-18 years
- Normal weight (BMI 5-85%-ile for age) or overweight (>85%-ile)
- With or without signs of excess androgen
- Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
Key exclusion criteria (16 listed)
- Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR #12702/JCM022. This protocol is designed to allow subjects enrolling in IRB-HSR #12702/JCM022 to simultaneously participate in this companion protocol.
- Inability to comprehend what will be done during the study or why it will be done
- BMI-for-age < 5th percentile
- Weight < 27 kg if simultaneously participating in IRB-HSR #12702/JCM022 due to blood volume limits
- Obesity associated with a diagnosed genetic syndrome (e.g. Prader-Willi syndrome)
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 |
|---|---|---|
| Dexamethasone1 mg PO | Drug | dexamethasone, rhCG (Ovidrel) |
| rhCGAlso: (Ovidrel)25 mcg IV | Drug | dexamethasone, rhCG (Ovidrel) |
Primary outcome
Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty
Time frame: 24 hours after administration of rhCG administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
Christine Burt Solorzano, MD principal investigator
University of Virginia Center for Research in Reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and rhCG in people with Polycystic Ovary Syndrome and Obesity, run by University of Virginia 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 16 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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?
Results are not available in the source record.
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?
Assess baseline and stimulated ovarian hormone levels in response to recombinant human chorionic gonadotropin (rhCG) administration in normal weight and overweight girls across puberty (time frame: 24 hours after administration of rhCG administration). 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 27 Oct 2023.