Acute PainEarly Phase 1NCT05781685
The Influence of Testosterone on Experimental Pain Perception
A Early Phase 1 study testing Testosterone in people with Acute Pain, run by University of New Mexico at 1 site in United States.
Trial summary
This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone). Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Testosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 17 Jul 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study.
Who cannot join
- The following criteria will exclude a participant from the study:
- Anyone that has a tree nut allergy.
- Women that are pregnant or may feel that they may be pregnant or breast-feeding.
- Anyone taking supplements that may influence their testosterone level.
- Anyone taking any kind of steroid that may increase their testosterone level.
- Anyone that smokes tobacco or uses smokeless tobacco.
Show all 10Show fewer
- Anyone that reports any condition associated with nerve damage.
- Anyone that is using hormonal contraceptive.
- Anyone who was sick or unwell at the time of screening.
- Each participant completed a Testosterone Pre-Screen form. This form asked each participant individually whether they are taking any drugs or have any conditions that might be exacerbated by testosterone. This form was completed before they signed the consent form and each time they arrived in the lab for an experimental session.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: The Influence of Testosterone on Experimental Pain Perception and Social Psychological Functioning
This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).
- Conditions
- Acute Pain
- Being tested
- Testosterone, Placebo Syrup
- Keywords
- testosterone, pain tolerance, estradiol, progesterone
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Sublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves.
Placebo SyrupOther
Oil-based sublingual product.
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Sublingual testosterone Receives: Drug: Testosterone; Other: Placebo Syrup |
| Placebo | Placebo comparator | Placebo Receives: Drug: Testosterone; Other: Placebo Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Tolerance
The ischemic discomfort task applied a sphygmomanometer (blood pressure cuff) 5 cm below their elbow. The cuff was inflated to 200 mmHg. Pain tolerance was measured by how long they could tolerate the ischemic discomfort task. However, task was only allowed to last for 6 minutes
Measured: 4 hours After Administration
Secondary outcomes (3)
Changes Testosterone Levels
The measured testosterone levels in the participants before and after receiving the intervention
Measured: Prior to Intervention (Baseline), 15 minutes Post Intervention
Changes Estradiol Levels
The measured estradiol levels in the participants before and after receiving the intervention.
Measured: Prior to Intervention (Baseline), 15 minutes Post Intervention
Changes Progesterone Levels
he measured progesterone levels in the participants before and after receiving the intervention.
Measured: Prior to Intervention (Baseline), 15 minutes Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start1 Oct 2017
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Association (APA)
- Responsible party
- Principal investigator, Chance Strenth, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781685
- Sponsor's protocol ID
- 1100595-3
- Status last verified
- Jul 2024
- First submitted
- 23 Feb 2023
- Last updated
- 5 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Testosterone on Experimental Pain Perception and Social Psychological Functioning
- ClinicalTrials.gov ID
- NCT05781685
- Acronym / sponsor ID
- 1100595-3
- Conditions
- Acute Pain
- Keywords
- testosterone, pain tolerance, estradiol, progesterone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- American Psychological Association (APA)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Posted 5 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial examined how the administration of exogenous testosterone would influence pain tolerance and other endogenous steroids (i.e. estradiol and progesterone).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: Testosterone, Other: Placebo SyrupSublingual testosterone |
| Placebo | Placebo comparator | Drug: Testosterone, Other: Placebo SyrupPlacebo |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy college-aged females that are over the age of 18 and younger than 25 will be used for this study.
Key exclusion criteria (10 listed)
- The following criteria will exclude a participant from the study:
- Anyone that has a tree nut allergy.
- Women that are pregnant or may feel that they may be pregnant or breast-feeding.
- Anyone taking supplements that may influence their testosterone level.
- Anyone taking any kind of steroid that may increase their testosterone 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 |
|---|---|---|
| TestosteroneSublingual testosterone was administered to participants. Participants would self-administer the testosterone to themselves. | Drug | Placebo, Testosterone |
| Placebo SyrupOil-based sublingual product. | Other | Placebo, Testosterone |
Primary outcome
Pain Tolerance
Time frame: 4 hours After Administration
The ischemic discomfort task applied a sphygmomanometer (blood pressure cuff) 5 cm below their elbow. The cuff was inflated to 200 mmHg. Pain tolerance was measured by how long they could tolerate the ischemic discomfort task. However, task was only allowed to last for 6 minutes
3 secondary outcomes
Changes Testosterone Levels
Time frame: Prior to Intervention (Baseline), 15 minutes Post Intervention
Changes Estradiol Levels
Time frame: Prior to Intervention (Baseline), 15 minutes Post Intervention
Changes Progesterone Levels
Time frame: Prior to Intervention (Baseline), 15 minutes Post Intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Testosterone in people with Acute Pain, run by University of New Mexico 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 1 inclusion and 10 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 5 Aug 2024. 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.
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?
Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Tolerance (time frame: 4 hours After 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 5 Aug 2024.