Icariin to Prevent Corticosteroid-related Memory Changes

Phase 1

Completed

• Conditions: the Pharmacokinetic Profile of Icariin in Humans
• Interventions: Dietary Supplement: Matching placebo; Drug: Icariin

• Registration Number: NCT02112123
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Matching placebo	Matching placebo given for 5 days (qd po)
Icariin - 100 mg/day	Icariin	Icariin given at 100 mg/day (qd po) for 5 days
Icariin - 200 mg/day	Icariin	Icariin given at 200 mg/day (qd po) for 5 days
Icariin - 400 mg/day	Icariin	Icariin given at 400 mg/day (qd po) for 5 days
Icariin - 840 mg/day	Icariin	Icariin given at 840 mg/day (qd po) for 5 days
Icariin - 1680 mg/day	Icariin	Icariin given at 1680 mg/day (qd po) for 5 days

Primary Outcome Measures

Name	Time	Method
Blood concentration levels of icariin	24 hours

Secondary Outcome Measures

Name	Time	Method
A-SEX	5 days	Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning.
SAFTEE	5 days	Systematic Assessment for Treatment Emergent Events - to assess general side effects
PT/PTT levels	5 days	Prothrombin time/Partial thromboplastin time

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States