NCT05891327

Brief Summary

The purpose of this study was to investigate the effects of Lepidium meyenii (Maca) extract supplementation on male sexual funtion.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

May 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 12, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 26, 2023

Last Update Submit

October 10, 2023

Conditions

Sexual Dysfunction Male

Outcome Measures

Primary Outcomes (30)

  • IIEF-5 score

    Baseline (before supplementation)

  • IIEF-5 score

    6 weeks of supplementation

  • IIEF-5 score

    12 weeks of supplementation

  • IIEF-5 score

    18 weeks of supplementation

  • IIEF-5 score

    24 weeks of supplementation

  • EHS score

    Baseline (before supplementation)

  • EHS score

    6 weeks of supplementation

  • EHS score

    12 weeks of supplementation

  • EHS score

    18 weeks of supplementation

  • EHS score

    24 weeks of supplementation

  • level of PSA

    Baseline (before supplementation)

  • level of PSA

    6 weeks of supplementation

  • level of PSA

    12 weeks of supplementation

  • level of PSA

    18 weeks of supplementation

  • level of PSA

    24 weeks of supplementation

  • Testosterone level

    Baseline (before supplementation)

  • Testosterone level

    6 weeks of supplementation

  • Testosterone level

    12 weeks of supplementation

  • Testosterone level

    18 weeks of supplementation

  • Testosterone level

    24 weeks of supplementation

  • LH level

    Baseline (before supplementation)

  • LH level

    6 weeks of supplementation

  • LH level

    12 weeks of supplementation

  • LH level

    18 weeks of supplementation

  • LH level

    24 weeks of supplementation

  • Level of FSH

    Baseline (before supplementation)

  • Level of FSH

    6 weeks of supplementation

  • Level of FSH

    12 weeks of supplementation

  • Level of FSH

    18 weeks of supplementation

  • Level of FSH

    24 weeks of supplementation

Study Arms (2)

Maca group

EXPERIMENTAL
Dietary Supplement: Maca

Placebo group

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

MacaDIETARY_SUPPLEMENT

2.25 g Lepidium meyenii (Maca) extract twice per day for 12 weeks

Maca group
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • evaluated as sexual dysfunction for more than three months by physician
  • international index of erectile function (IIEF) score is less than or equal to 21
  • erectile hardness score (EHS) score is less than or equal to 3
  • aged over 18 years old

You may not qualify if:

  • unable to cooperate with the course of the treatment
  • suffering from sexually transmitted diseases such as Syphilis, AIDS and HPVs
  • had Radical Prostatectomy (total removal of the prostate gland)
  • suffering from active tumors in the prostate or pelvic area
  • suffering from Hypogonadism
  • anatomical deformation of the penis
  • men with penile prosthesis
  • suffering from psychotic disorder (manic disorder, chronic depression, etc.)
  • suffering from neurological diseases (multiple sclerosis, brain or spinal cord injuries, etc.)
  • using Permanent pacemaker
  • considered unsuitable to participate in this experiment according to the doctor
  • alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Interventions

MacA protein, E coli

Central Study Contacts

Ming Ta Yang, Doctorate

CONTACT

886-2-27361661yangrugby@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
A double-blind, matched-pair study design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: assign 60 participants into the experimental group (n = 30) or placebo group (n = 30)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 6, 2023

Study Start

December 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

October 12, 2023

Record last verified: 2023-05

Locations

TW(1)