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OpenTrials
Completed

NCT Number: NCT02112123

Icariin to Prevent Corticosteroid-related Memory Changes

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Icariin

Drug

Other names: Horny Goat Weed, epimedium extract

Matching Placebo

Dietary Supplement

Primary outcomes

  1. Blood concentration levels of icariin

    Time frame: 24 hours

Secondary outcomes

  1. A-SEX

    Time frame: 5 days

    Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning.

  2. SAFTEE

    Time frame: 5 days

    Systematic Assessment for Treatment Emergent Events - to assess general side effects

  3. PT/PTT levels

    Time frame: 5 days

    Prothrombin time/Partial thromboplastin time

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2014
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.