Status:
UNKNOWN
Effect of Different Ingestion Doses of Celastrol on Human Sperm Motility
Lead Sponsor:
Legend Labz, Inc.
Conditions:
Safety Issues
Eligibility:
MALE
18-40 years
Phase:
NA
Brief Summary
Five healthy participants with normal sperm counts and motility will ingest increasing doses of celastrol over a period of several days. After each dose ingestion the participants will provide an ejac...
Detailed Description
Experimental Design This will be an escalating dose study to determine the effects of different enteral dosages on sperm motility. Five healthy participants, of any ethnicity, between 18 and 40 years ...
Eligibility Criteria
Inclusion
- Individuals who are between 18 and 40 years of age and who are found to be healthy without any underlying medical conditions that could affect sperm motility, and are not taking any daily medications. This does not exclude patients who take drugs prn.
- Individuals who have not be involved in other clinical trials during the last 90 days. -
Exclusion
- Individuals who have been involved in any other clinical trial during the last 90 days.
- Individuals who have sperm counts lower than that considered "normal." i.e. a sperm count of \~20 million sperm per milliliter of ejaculate, and (b) sperm motility of ≥ 40% one hour after ejaculate.
- Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
- Individuals on medications that the clinician feels may affect sperm motility and/or otherwise interfere with the results
- Medications that might interfere with blood chemistry, or CBCs
- Subjects who are taking daily medications. The use of therapies prn is allowed.
- Subjects Less than 18 years of age or over 40 years of age
- Prisoners
- Subjects who have taken anabolic steroid or testosterone during the last six months.
- Subjects with a current history of addictive alcohol or illegal drug abuse (e.g. cocaine, heroin, etc.).
- The use of marijuana is allowed, but not preferred.
- Subjects who are taking 5-alpha-reductase inhibitors (finasteride (Propecia®) and dutasteride (Avodart®), or Chemotherapy: -
- Smokers
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05413226
Start Date
September 28 2021
End Date
July 15 2022
Last Update
June 9 2022
Active Locations (1)
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1
Patient Urgent Care Clinic
Baton Rouge, Louisiana, United States, 70808