HyperandrogenemiaEarly Phase 1NCT01422096
Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess
A Early Phase 1 study testing Leuprolide in people with Hyperandrogenemia and Obesity, run by University of Virginia at 1 site in United States.
Trial summary
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen… Read more about this study
- Who is it for?
- Ages 7 to 18 years, women only
- Conditions the study is for
- Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
- What is being tested?
- Leuprolide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 17 Jul 2018
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- overweight (>85th BMI%) females
- Early to late puberty (expected age range 7-18)
- Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
- 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
- Screening labs outside of age-appropriate normal range
- Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
- Morning Cortisol <5 g/dL
- 17-hydroxyprogesterone >295 ng/dL
- History of Cushing's syndrome or adrenal insufficiency
- Pregnant
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
Official title: Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
- Conditions
- Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
- Being tested
- Leuprolide
- Medical subject headings
- Obesity, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprolideDrug
Also called Depot Lupron
depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if > 37.5 kg im once
| Study group | Role | What they receive |
|---|---|---|
| leuprolide | Experimental | leuprolide 11.25 mg IM with adrenal suppression/stimulation testing with dexamethasone/Cortrosyn and ovarian stimulation testing with r-hCG before and 3 weeks after injection Receives: Drug: Leuprolide |
What is being measured
The primary outcome is the main question the study is designed to answer.
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
Measured: 4 weeks after leuprolide
Secondary outcomes (1)
Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration
Measured: 4 weeks after leuprolide
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 start1 Jun 2018
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Why it stopped: The study team decided not to pursue this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenemiaStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Burt Solorzano, University of Virginia
- Investigators
- Christine M. Burt Solorzano, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422096
- Sponsor's protocol ID
- CBS007
- Other IDs
- CBS007
- Status last verified
- Jul 2018
- First submitted
- 19 Aug 2011
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS007)
- ClinicalTrials.gov ID
- NCT01422096
- Acronym / sponsor ID
- CBS007
- Conditions
- Hyperandrogenemia, Obesity, Polycystic Ovary Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team decided not to pursue this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- 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.
This study will test whether short-term suppression of ovarian function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one dose of depot leuprolide agonist administration will improve androgen levels in girls with ovarian androgen overproduction. Specifically, this intervention will improve androgen levels after ovarian stimulation testing with recombinant human chorionic gonadotropin (rhCG).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| leuprolide | Experimental | Drug: Leuprolideleuprolide 11.25 mg IM with adrenal suppression/stimulation testing with dexamethasone/Cortrosyn and ovarian stimulation testing with r-hCG before and 3 weeks after injection |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- overweight (>85th BMI%) females
- Early to late puberty (expected age range 7-18)
- Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
- 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 (6 listed)
- Screening labs outside of age-appropriate normal range
- Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
- Morning Cortisol <5 g/dL
- 17-hydroxyprogesterone >295 ng/dL
- History of Cushing's syndrome or adrenal insufficiency
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 |
|---|---|---|
| LeuprolideAlso: Depot Luprondepot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if > 37.5 kg im once | Drug | leuprolide |
Primary outcome
17 hydroxyprogesterone responses to rhCG before and 4 weeks after depot leuprolide administration
Time frame: 4 weeks after leuprolide
1 secondary outcome
Ovarian hormone precursor responses to rhCG before and 4 weeks after depot leuprolide administration
Time frame: 4 weeks after leuprolide
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Hyperandrogenemia
Active, not recruiting
Evaluating the Influence of Diet-induced Weight Loss on Fat (Adipose) Tissue's Insulin Sensitivity and Testosterone Synthesis in Women With Overweight or Obesity, Insulin Resistance, and Hyperandrogenemia
Overweight and Obesity, Hyperandrogenemia
Recruiting
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
Polycystic Ovary Syndrome
RecruitingEarly Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
Puberty, Hyperandrogenism
RecruitingEarly Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
Hyperandrogenism, Polycystic Ovary Syndrome
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 M. Burt Solorzano, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Leuprolide in people with Hyperandrogenemia 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 6 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: withdrawn, as of the sponsor's last update on 19 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 rhCG before and 4 weeks after depot leuprolide administration (time frame: 4 weeks after leuprolide). 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 19 Jul 2018.