Recruiting

Celastrol

Sponsor:

Legend Labz, Inc.

Code:

NCT05413226

Conditions

Safety Issues

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Celastrol

Study Details

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 ejaculate the next day for sperm analysis. The objective is to see if increasing ingestion levels of celastrol will affect the sperm counts and motility of the participants.

Conditions

Safety Issues

Study ID

NCT05413226

Start date

Sep 28, 2021

Status verified date

Jun, 2022

Completion date

Jul 15, 2022

Anticipated

Primary completion date

Jul 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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.
2. Individuals who have not be involved in other clinical trials during the last 90 days. -

Exclusion Criteria:

1. Individuals who have been involved in any other clinical trial during the last 90 days.
2. 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.
3. Clinically significant cardiac disease including uncontrolled congestive heart failure and unstable angina
4. Individuals on medications that the clinician feels may affect sperm motility and/or otherwise interfere with the results
5. Medications that might interfere with blood chemistry, or CBCs
6. Subjects who are taking daily medications. The use of therapies prn is allowed.
7. Subjects Less than 18 years of age or over 40 years of age
8. Prisoners
9. Subjects who have taken anabolic steroid or testosterone during the last six months.
10. 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.
11. Subjects who are taking 5-alpha-reductase inhibitors (finasteride (Propecia®) and dutasteride (Avodart®), or Chemotherapy: -
12. Smokers

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Amount of Celastrol Administered

Increasing doses of Celastrol to each of five male subjects

Interventions

Celastrol

Four increasing doses of Celastrol to each of five men.

Primary outcome measure

  • Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion [ Time Frame: One Month ]
  • Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion [ Time Frame: One Month ]

Central Contacts and Locations

Central contacts

Locations

Patient Urgent Care Clinic

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

More Information

Sponsor

Legend Labz, Inc.

Last update posted

Jun 9, 2022

Last verified

Jun, 2022

Keywords

  • sperm motility
  • sperm count
  • celastrol

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Legend Labz, Inc. on 2022-06-09.