HyperandrogenismNCT01753037
Effects of Androgen Administration on Inflammation in Normal Women
A study testing Dehydroepiandrosterone (DHEA) in people with Hyperandrogenism, run by Mayo Clinic at 1 site in United States.
Trial summary
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperandrogenism
- What is being tested?
- Dehydroepiandrosterone (DHEA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Apr 2010
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Acceptable health based on interview, medical history, physical examination and lab tests
- Ability to comply with requirements of the study
- Ability and willingness to provide signed, witnessed informed consent
- Between the ages of 18-40 years
- Body mass index between 18 and 25
- Normal regular monthly periods
- No clinical evidence of androgen excess
- No evidence of polycystic ovaries on ultrasound
Who cannot join
- Diabetes mellitus
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
- High blood pressure
- Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
- Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
- Known hypersensitivity to DHEA
Show all 11Show fewer
- Two first-degree relatives with breast cancer or ovarian cancer
- Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism
- Tobacco smoking
- Ingestion of any investigational drugs within 4 weeks prior to study onset
- Pregnancy or lactation (less than or equal to 6 weeks postpartum)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.
- Conditions
- Hyperandrogenism
- Being tested
- Dehydroepiandrosterone (DHEA), Placebo
- Keywords
- Hyperandrogenism, Inflammation, Insulin sensitivity, Body composition
- Medical subject headings
- Hyperandrogenism, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dehydroepiandrosterone (DHEA)Dietary supplement
DHEA 130 mg administered orally for 5 days.
PlaceboOther
Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| DHEA Group | Active comparator | Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days. Receives: Dietary Supplement: Dehydroepiandrosterone (DHEA) |
| Placebo Group | Placebo comparator | Oral administration of an identical capsule containing placebo for 5 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nuclear factor kappa B (NFkappaB) activation
White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration.
Measured: 0 and 2 hours after glucose ingestion
Secondary outcomes (1)
Insulin sensitivity
Insulin sensitivity derived from an oral glucose tolerance test (OGTT) will be assessed before and after 5 days of DHEA or placebo administration.
Measured: 0 and 5 days after DHEA or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperandrogenismStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Gonzalez, Mayo Clinic
- Investigators
- Frank González, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753037
- Sponsor's protocol ID
- Mayo-06-004680
- Status last verified
- Dec 2012
- First submitted
- 15 Dec 2012
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women
- ClinicalTrials.gov ID
- NCT01753037
- Acronym / sponsor ID
- Mayo-06-004680
- Conditions
- Hyperandrogenism
- Keywords
- Hyperandrogenism, Inflammation, Insulin sensitivity, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Dec 2012 (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.
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHEA Group | Active comparator | Dietary Supplement: Dehydroepiandrosterone (DHEA)Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days. |
| Placebo Group | Placebo comparator | Other: PlaceboOral administration of an identical capsule containing placebo for 5 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Acceptable health based on interview, medical history, physical examination and lab tests
- Ability to comply with requirements of the study
- Ability and willingness to provide signed, witnessed informed consent
- Between the ages of 18-40 years
- Body mass index between 18 and 25
Key exclusion criteria (11 listed)
- Diabetes mellitus
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
- High blood pressure
- Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
- Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
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 |
|---|---|---|
| Dehydroepiandrosterone (DHEA)DHEA 130 mg administered orally for 5 days. | Dietary supplement | DHEA Group |
| PlaceboPlacebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days. | Other | Placebo Group |
Primary outcome
Nuclear factor kappa B (NFkappaB) activation
Time frame: 0 and 2 hours after glucose ingestion
White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration.
1 secondary outcome
Insulin sensitivity
Time frame: 0 and 5 days after DHEA or placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
Related trials for Hyperandrogenism
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
RecruitingObservational study
Polycystic Ovary Syndrome in Type 1 Diabetes
Type 1 Diabetes Mellitus, Polycystic Ovary Syndrome (PCOS)
Recruiting
Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)
PCOS (Polycystic Ovary Syndrome), Obese Adolescents
Recruiting
This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.
Polycystic Ovarian Syndrome (PCOS)
Not yet recruitingObservational study
Biomarker Panel for PCOS-Associated Liver Steatosis in Adolescent Girls (COMPASS-pedPCOS)
Polycystic Ovary Syndrome (PCOS), Metabolic Dysfunction-Associated Steatotic Liver Disease
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.
Frank González, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dehydroepiandrosterone (DHEA) in people with Hyperandrogenism, run by Mayo Clinic 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 8 inclusion and 11 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 18 Nov 2013. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nuclear factor kappa B (NFkappaB) activation (time frame: 0 and 2 hours after glucose ingestion). 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 18 Nov 2013.