Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health

December 26, 2017 updated by: Supplement Formulators, Inc.

An Open Label Study to Evaluate the Effect of Kaempferia Parviflora in Support of Erectile Function and Male Sexual Health Among Overall Healthy Males 50-70.

The purpose of this study was to evaluate the overall efficacy and safety of Kaempferia parviflora in overall healthy male human subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was an open label safety and efficacy study. Each subject received a specific dose of a formulation containing Kaempferia parviflora. There would be attempted telephone or e-mail contact in 2 weeks following enrollment.

Participants would undergo assessments of blood tests, vital signs, body weight with completion of questionnaires.

The primary objective was to assess the effect of Kaempferia parviflora on erectile function among overall healthy males age 50 to 70.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Primary Inclusion Criteria:

  1. Healthy male volunteers between the age of 50-70 inclusive
  2. Having been (or attempted to be) sexually active for at least the last 6 months
  3. Having been in a stable sexual relationship for the past 6 months or more
  4. Be able to comply with a 14-day washout period of all sexual performance enhancing medications, nutritional supplements or herbs prior to Day 1 randomization
  5. Be able to comply with a 14-day washout period of all nutritional supplements that may contain any of the components of the formulation prior to Day 1 enrollment

Primary Exclusion Criteria:

  1. Having a Body Mass Index greater than 34.9
  2. Currently receiving or having received treatment in the past 6 months for any sexual disorder or dysfunction (including treatment for erectile function, intercourse satisfaction, orgasmic function, or sexual desire)
  3. Attain a score of < 16 on the IIEF-5 questionnaire
  4. Primary diagnosis of another sexual disorder (e.g., premature ejaculation)
  5. Currently taking supplements including Kaempferia parviflora, DHEA (Dehydroepiandrosterone), chrysin, pregnenolone, grape seed extract, bitter orange, country mallow, ephedra, bitter melon, catuaba, horny goat weed, mucuna pruriens, maca, tribulus terrestris, muira puama, yohimbe or sativa, fenugreek, tongkat ali, Activali, Eurycoma longifolia Jack and goat's rue or any other supplement which has effects on sexual health. Also, testosterone and aromatase inhibitors (letrozole, anastrozole, exemestane, tesolactone) and phosphodiesterase type 5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) unless willing to washout 14 days prior to baseline
  6. Having any of the following disorders: benign prostatic hyperplasia (BPH), diabetes mellitus, cancer (including prostate and male breast cancer), insomnia, sleep apnea, heart disease, hypertension, renal disease, liver disease, vascular disease, endocrine abnormalities (e.g. hypogonadism or hypo/hyperthyroidism), multiple sclerosis, psychiatric disorder, acute genitourinary disorder, history of spinal cord injury, herniated disc, penile injury or disease (e.g. Peyronie's disease, priapism or genital anatomic abnormalities) or any other significant medical or surgical procedure that precludes participation in the judgment of the investigator/sub-investigator
  7. Currently taking medications for benign prostatic hyperplasia (e.g. tamsulosin, dutasteride, finasteride, terazosin), theophylline medications, antihypertensive medications (e.g. diuretics, sympatholytics, beta blockers, calcium channel blockers), antidiabetic medications, psychiatric medications (e.g. antipsychotic agents, antidepressants, or anxiolytic agents), androgenic and antiandrogenic medications, digitalis, histamine H2-receptor blockers, ketoconazole, niacin, MAOI (monoamine oxidase inhibitor) (e.g. phenelzine), phenobarbital, phenytoin, anticoagulants (e.g. warfarin, high dose aspirin, cilostazol [Pletal], clopidogrel [Plavix], dalteparin [Fragmin], enoxaparin [Lovenox], heparin, ticlopidine [Ticlid]) or receiving nitrate therapy -
  8. Laboratory: bilirubin > 2 x ULN (Upper limit of normal) , AST/SGOT (aspartate aminotransferase/serum glutamic oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic pyruvic transaminase) ( > 2 x ULN, serum creatinine > 1.5 mg/dL, total cholesterol > 347.9mg/dl, triglycerides > 300mg/dl, and PSA > 4 ng/mL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Male Sexual Health Formulation
Kaempferia parviflora extract 100mg daily
Dietary supplement: Kaempferia parviflora extract
Other Names:
  • KaempMax™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IIEF (International Index of Erectile Dysfunction) questionnaire scores
Time Frame: 30 days
Mean change in IIEF scores. There are five specific areas addressed including Erectile Function (questions:1-5 & 15;score range: 0-5, maximum score:30); Orgasmic Function (questions:9-10; score range:0-5; maximum score:10); Sexual desire (questions:11-12; score range:1-5; maximum score:10); Intercourse satisfaction (questions:6-8; score range:0-5; maximum score:15); Overall satisfaction (questions:13-14; score range:1-5; maximum score:10). The lower the score represents greater dysfunction within each domain.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GAQ (Global Assessment Question)
Time Frame: 30 days
Response (yes or no) from Global Assessment Question
30 days
Levels of Free Testosterone
Time Frame: 30 days
Mean change in Free Testosterone levels in pg/ml
30 days
Levels of Total Testosterone
Time Frame: 30 days
Mean change in Total Testosterone levels in ng/dl
30 days
Levels of Estradiol
Time Frame: 30 days
Mean change in Estradiol levels in pg/ml
30 days
Levels of DHEA-S
Time Frame: 30 days
Mean change in DHEA-S levels in ug/dl
30 days
Levels of PSA
Time Frame: 30 days
Mean change in PSA levels in ng/ml
30 days
Levels of Total Cholesterol
Time Frame: 30 days
Mean change in Total Cholesterol levels in mg/dl
30 days
Levels of LDL Cholesterol
Time Frame: 30 days
Mean change in LDL Cholesterol levels in mg/dl
30 days
Levels of HDL Cholesterol
Time Frame: 30 days
Mean change in HDL Cholesterol levels in mg/dl
30 days
Levels of Triglycerides
Time Frame: 30 days
Mean change in Triglyceride levels in mg/dl
30 days
Body Mass Index
Time Frame: 30 days
Mean change in body mass index in kg/m^2 calculated by formula using the body weight (lb.) and the height (in.)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Investigators

  • Principal Investigator: Steven Joyal, Life Extension

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2014

Primary Completion (Actual)

November 29, 2015

Study Completion (Actual)

March 15, 2016

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 26, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

December 26, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CL073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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