Hypogonadism, MaleNCT03541395
Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males
A study testing GnRH antagonist in people with Hypogonadism, Male, run by Lund University.
Trial summary
The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Male
- What is being tested?
- GnRH antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2015
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
Who cannot join
- use of anabolic steroids, use of narcotics,
About this study
Official title: Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration
The study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.
- Conditions
- Hypogonadism, Male
- Being tested
- GnRH antagonist
- Medical subject headings
- Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GnRH antagonistDrug
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Other | A Gonadotropin releasing hormone agonist (GnRH-agonist) is administered to lower the testosterone to castration levels. After four weeks testosterone undecanoate is administered to increase the testosterone to normal levels. Receives: Drug: GnRH antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein biomarkers
Finding new protein biomarkers related to testosterone response
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study startMar 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism, MaleStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Malm, Lund University
- Investigators
- Johan Malm, MD, Study chair, Lund UniversityRoger Appelqvist, PhD, Principal investigator, Lund UniversityGyorgy Marko-Varga, PhD, Principal investigator, Lund UniversityAleksander Giwercman, MD, Principal investigator, Lund UniversityBarbara Sahlin, MSc, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541395
- Sponsor's protocol ID
- TP 001
- Status last verified
- May 2018
- First submitted
- 16 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone-Dependent Effects on Protein Biomarkers From Healthy Males Before and After Pharmacological Castration
- ClinicalTrials.gov ID
- NCT03541395
- Acronym / sponsor ID
- TP 001
- Conditions
- Hypogonadism, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 May 2018 (actual)
- 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 study is designed to identify and validate new protein biomarkers in blood related to testosterone activity. Thirty healthy young males underwent pharmaceutical castration to lower testosterone levels. After three weeks the subjects received an intramuscular injection of testosterone undecanoate. Blood samples from just before pharmaceutical castration, three weeks after castration, and one week after injection of testosterone undecanoate were collected representing normal testosterone levels, low testosterone levels, and testosterone at eugonadal levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Other | Drug: GnRH antagonistA Gonadotropin releasing hormone agonist (GnRH-agonist) is administered to lower the testosterone to castration levels. After four weeks testosterone undecanoate is administered to increase the testosterone to normal levels. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy males
Key exclusion criteria (1 listed)
- use of anabolic steroids, use of narcotics,
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 |
|---|---|---|
| GnRH antagonist | Drug | Testosterone |
Primary outcome
Protein biomarkers
Time frame: 48 months
Finding new protein biomarkers related to testosterone response
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 30 May 2018.
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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.
Johan Malm, MD study chair
Lund University
Roger Appelqvist, PhD principal investigator
Lund University
Gyorgy Marko-Varga, PhD principal investigator
Lund University
Questions about this trial
What is this clinical trial studying?
A study testing GnRH antagonist in people with Hypogonadism, Male, run by Lund University.
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 1 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: finished, as of the sponsor's last update on 30 May 2018. 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. 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?
Protein biomarkers (time frame: 48 months). 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 30 May 2018.