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Icariin to Prevent Corticosteroid-related Memory Changes

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Texas Southwestern Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02112123
First received: April 9, 2014
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
the Pharmacokinetic Profile of Icariin in Humans
Dietary Supplement: Icariin
Dietary Supplement: Matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Icariin to Prevent Corticosteroid-related Memory Changes

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Blood concentration levels of icariin [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A-SEX [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Arizona Sexual Experiences Scale for measuring side effects relating to sexual functioning.

  • SAFTEE [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Systematic Assessment for Treatment Emergent Events - to assess general side effects

  • PT/PTT levels [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    Prothrombin time/Partial thromboplastin time


Estimated Enrollment: 24
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Matching placebo given for 5 days (qd po)
Dietary Supplement: Matching placebo
Active Comparator: Icariin - 100 mg/day
Icariin given at 100 mg/day (qd po) for 5 days
Dietary Supplement: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 200 mg/day
Icariin given at 200 mg/day (qd po) for 5 days
Dietary Supplement: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 300 mg/day
Icariin given at 300 mg/day (qd po) for 5 days
Dietary Supplement: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract
Active Comparator: Icariin - 400 mg/day
Icariin given at 400 mg/day (qd po) for 5 days
Dietary Supplement: Icariin
Other Names:
  • Horny Goat Weed
  • epimedium extract

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, 300 mg/day, or 400 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women
  • Ages 18 - 50 years
  • BMI between 18.5 and 30
  • Ability to read and speak English

Exclusion Criteria:

  • Medication changes in the past 30 days
  • Current or past 30 days opioid therapy
  • Current or past 30 days erectile dysfunction therapy
  • Significant medical conditions
  • 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
  • Clinically significant abnormalities on baseline labs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112123

Contacts
Contact: Kimberly K Anderson, BS 214-645-6954 kimberlyk.anderson@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Kimberly K Anderson, BS    214-645-6954    kimberlyk.anderson@utsouthwestern.edu   
Principal Investigator: E. Sherwood Brown, M.D., Ph.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: E. Sherwood Brown, M.D., Ph.D. UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Sherwood Brown, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02112123     History of Changes
Other Study ID Numbers: 102012-052, 1R21AT007869-01
Study First Received: April 9, 2014
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
icariin
pharmacokinetics
healthy participants

ClinicalTrials.gov processed this record on July 20, 2014