HypertensionNCT02269072
Testosterone Regulation of the Natriuretic Peptide System
A study testing Testosterone, Nesiritide and Leuprolide in people with Hypertension, run by Massachusetts General Hospital.
Trial summary
The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Testosterone, Nesiritide and Leuprolide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25.
- Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25.
Who cannot join
- Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.
About this study
The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.
- Conditions
- Hypertension
- Being tested
- Testosterone, Nesiritide, Leuprolide, Anastrozole, Placebo
- Keywords
- Natriuretic Peptide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Testosterone cream applied daily for two weeks
NesiritideDrug
Administered IV once during the study
LeuprolideDrug
Administered twice during the study by injection
AnastrozoleDrug
Daily pill for 8 weeks
PlaceboDrug
Inert cream otherwise identical to testosterone cream applied daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Active comparator | Testosterone cream applied daily Receives: Drug: Testosterone; Drug: Nesiritide; Drug: Leuprolide; Drug: Anastrozole |
| Placebo | Placebo comparator | Identical placebo cream applied daily Receives: Drug: Nesiritide; Drug: Leuprolide; Drug: Anastrozole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial natriuretic peptide levels
Measured: 8 weeks
Secondary outcomes (1)
Urinary salt excretion
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Klahr Miller, MD, Massachusetts General Hospital
- Investigators
- Karen K Miller, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269072
- Sponsor's protocol ID
- 2014P00
- Status last verified
- Oct 2017
- First submitted
- 15 Oct 2014
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Regulation of the Natriuretic Peptide System
- ClinicalTrials.gov ID
- NCT02269072
- Acronym / sponsor ID
- 2014P00
- Conditions
- Hypertension
- Keywords
- Natriuretic Peptide
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 20 Oct 2014 (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 proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Active comparator | Drug: Testosterone, Drug: Nesiritide, Drug: Leuprolide, Drug: AnastrozoleTestosterone cream applied daily |
| Placebo | Placebo comparator | Drug: Nesiritide, Drug: Leuprolide, Drug: Anastrozole, Drug: PlaceboIdentical placebo cream applied daily |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25.
- Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25.
Key exclusion criteria (1 listed)
- Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.
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 |
|---|---|---|
| TestosteroneTestosterone cream applied daily for two weeks | Drug | Testosterone |
| NesiritideAdministered IV once during the study | Drug | Placebo, Testosterone |
| LeuprolideAdministered twice during the study by injection | Drug | Placebo, Testosterone |
| AnastrozoleDaily pill for 8 weeks | Drug | Placebo, Testosterone |
| PlaceboInert cream otherwise identical to testosterone cream applied daily for two weeks | Drug | Placebo |
Primary outcome
Atrial natriuretic peptide levels
Time frame: 8 weeks
1 secondary outcome
Urinary salt excretion
Time frame: 8 weeks
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 Oct 2017.
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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.
Karen K Miller, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Testosterone, Nesiritide and Leuprolide in people with Hypertension, run by Massachusetts General Hospital.
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 2 inclusion and 1 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Atrial natriuretic peptide levels (time frame: 8 weeks). 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 Oct 2017.