NCT05413226

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 28, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

10 months

First QC Date

July 24, 2021

Last Update Submit

June 7, 2022

Conditions

Safety Issues

Keywords

sperm motilitysperm countcelastrol

Outcome Measures

Primary Outcomes (2)

  • Motility of Sperm in 1 mL of Ejaculate after Celastrol Ingestion

    Sperm samples will be analyzed independently for sperm motility

    One Month

  • Amount of Sperm in 1 mL of Ejaculate after Celastrol Ingestion

    Sperm samples will be analyzed independently for number of sperm

    One Month

Study Arms (1)

Amount of Celastrol Administered

EXPERIMENTAL

Increasing doses of Celastrol to each of five male subjects

Dietary Supplement: Celastrol

Interventions

CelastrolDIETARY_SUPPLEMENT

Four increasing doses of Celastrol to each of five men.

Also known as: 24,25,26-trinoroleana-1(10),3,5,7- tetraen-29-oic acid
Amount of Celastrol Administered

Eligibility Criteria

Age18 Years - 40 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsNon-Smoking Healthy Males
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patient Urgent Care Clinic

Baton Rouge, Louisiana, 70808, United States

RECRUITING

MeSH Terms

Interventions

celastrol

Study Officials

  • Rubin Patel, MD

    Legend Labz, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rubin Patel, MD

CONTACT

225-224-8690rubin@patientplusuc.com

Sarah C Cabellero

CONTACT

225-224-8690scabal4@lsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The participants will be masked to the dose
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Healthy males from 18 to 40 years old
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2021

First Posted

June 9, 2022

Study Start

September 28, 2021

Primary Completion

July 15, 2022

Study Completion

July 15, 2022

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)