the Pharmacokinetic Profile of Icariin in HumansPhase 1NCT02112123
Icariin to Prevent Corticosteroid-related Memory Changes
A Phase 1 study testing Icariin in people with the Pharmacokinetic Profile of Icariin in Humans, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- the Pharmacokinetic Profile of Icariin in Humans
- What is being tested?
- Icariin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2016
- Phase
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Ages 18 - 50 years
- BMI between 18.5 and 30
- Ability to read and speak English
- Education of 12 or more years or equivalent (at least GED received)
Who cannot join
- Medication changes in the past 30 days
- History of psychotropic medication therapy in the past 30 days
- Current or past 30 days opioid therapy
- Current or past 30 days erectile dysfunction therapy
- Significant medical conditions
- Hypertensive blood pressure, defined as either systolic pressure > 140 or diastolic pressure > 90
Show all 15Show fewer
- Baseline heart rate > 100 bpm or < 50 bpm
- History of major psychiatric illness
- History of drug/alcohol abuse or current tobacco use
- Vulnerable populations including pregnant or nursing women, the incarcerated, or individuals with severe cognitive disorders
- History of allergic reaction or contraindication to icariin
- Baseline QIDS score > 7, current suicidal ideation, or history of suicide attempt
- Education history that includes Special Education or history of mental disability
- Clinically significant abnormalities on baseline labs and ECG results
- Current participation in any other pharmacotherapy studies
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.
Read the detailed description
The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.
Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.
24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.
- Being tested
- Icariin, Matching placebo
- Keywords
- icariin, pharmacokinetics, healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcariinDrug
Also called Horny Goat Weed, epimedium extract
Matching placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo given for 5 days (qd po) Receives: Dietary Supplement: Matching placebo |
| Icariin - 100 mg/day | Active comparator | Icariin given at 100 mg/day (qd po) for 5 days Receives: Drug: Icariin |
| Icariin - 200 mg/day | Active comparator | Icariin given at 200 mg/day (qd po) for 5 days Receives: Drug: Icariin |
| Icariin - 400 mg/day | Active comparator | Icariin given at 400 mg/day (qd po) for 5 days Receives: Drug: Icariin |
| Icariin - 840 mg/day | Active comparator | Icariin given at 840 mg/day (qd po) for 5 days Receives: Drug: Icariin |
| Icariin - 1680 mg/day | Active comparator | Icariin given at 1680 mg/day (qd po) for 5 days Receives: Drug: Icariin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration levels of icariin
Measured: 24 hours
Secondary outcomes (3)
A-SEX
Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning.
Measured: 5 days
SAFTEE
Systematic Assessment for Treatment Emergent Events - to assess general side effects
Measured: 5 days
PT/PTT levels
Prothrombin time/Partial thromboplastin time
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Pharmacokinetic Profile of Icariin in HumansStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Sherwood Brown, University of Texas Southwestern Medical Center
- Investigators
- E. Sherwood Brown, M.D., Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112123
- Sponsor's protocol ID
- 102012-052
- Other IDs
- 1R21AT007869-01
- Status last verified
- Aug 2017
- First submitted
- 9 Apr 2014
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Icariin to Prevent Corticosteroid-related Memory Changes
- ClinicalTrials.gov ID
- NCT02112123
- Acronym / sponsor ID
- 102012-052
- Keywords
- icariin, pharmacokinetics, healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Apr 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 purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.
Detailed description
The purpose of this study is to investigate the pharmacokinetic properties of icariin, an active ingredient in the over-the-counter supplement, Horny Goat Weed.
Healthy volunteers will be randomly assigned to a 5 day course of icariin at 100 mg/day, 200 mg/day, 400 mg/day, or 800 mg/day, or a matching placebo.
24 hours of blood samples will be drawn for pharmacokinetic analysis. Side effects will be assessed for the full 5 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Matching placeboMatching placebo given for 5 days (qd po) |
| Icariin - 100 mg/day | Active comparator | Drug: IcariinIcariin given at 100 mg/day (qd po) for 5 days |
| Icariin - 200 mg/day | Active comparator | Drug: IcariinIcariin given at 200 mg/day (qd po) for 5 days |
| Icariin - 400 mg/day | Active comparator | Drug: IcariinIcariin given at 400 mg/day (qd po) for 5 days |
| Icariin - 840 mg/day | Active comparator | Drug: IcariinIcariin given at 840 mg/day (qd po) for 5 days |
| Icariin - 1680 mg/day | Active comparator | Drug: IcariinIcariin given at 1680 mg/day (qd po) for 5 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women
- Ages 18 - 50 years
- BMI between 18.5 and 30
- Ability to read and speak English
- Education of 12 or more years or equivalent (at least GED received)
Key exclusion criteria (15 listed)
- Medication changes in the past 30 days
- History of psychotropic medication therapy in the past 30 days
- Current or past 30 days opioid therapy
- Current or past 30 days erectile dysfunction therapy
- Significant medical conditions
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 |
|---|---|---|
| IcariinAlso: Horny Goat Weed, epimedium extract | Drug | Icariin - 100 mg/day, Icariin - 1680 mg/day, Icariin - 200 mg/day, Icariin - 400 mg/day, Icariin - 840 mg/day |
| Matching placebo | Dietary supplement | Placebo |
Primary outcome
Blood concentration levels of icariin
Time frame: 24 hours
3 secondary outcomes
A-SEX
Time frame: 5 days
SAFTEE
Time frame: 5 days
PT/PTT levels
Time frame: 5 days
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 Aug 2017.
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.
E. Sherwood Brown, M.D., Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Icariin in people with the Pharmacokinetic Profile of Icariin in Humans, run by University of Texas Southwestern Medical Center 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 5 inclusion and 15 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 Aug 2017. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Blood concentration levels of icariin (time frame: 24 hours). 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 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.