UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023070
Receipt number R000026592
Scientific Title Evaluation of efficacy and safety profiles of tribulus terristrus in males with partial androgen deficiency and erectile dysfunction and lower urinary tract symptoms in a placebo controlled study
Date of disclosure of the study information 2016/07/08
Last modified on 2018/04/12 16:44:09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of efficacy and safety profiles of tribulus terristrus in males with partial androgen deficiency and erectile dysfunction and lower urinary tract symptoms in a placebo controlled study

Acronym

Safety and efficacy of tribulus terristrus in PADAM patients with erectile dysfunction and LUTS in a placebo controlled study

Scientific Title

Evaluation of efficacy and safety profiles of tribulus terristrus in males with partial androgen deficiency and erectile dysfunction and lower urinary tract symptoms in a placebo controlled study

Scientific Title:Acronym

Safety and efficacy of tribulus terristrus in PADAM patients with erectile dysfunction and LUTS in a placebo controlled study

Region

Africa


Condition

Condition

partial androgen deficiency with erectile dysfunction and low libido

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

potential roles of mesterolone and tribulus terristrus in PADAM patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Not yet available as the study is pre-intiating

Key secondary outcomes

Not yet available as the study is pre-intiating


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

one group of the PADAM patients will recieve placebo 3 times daily for 3 months with follow up of PSA / liver enzymes/ testosterone/ international prostate symptoms score (IPSS)/ validated Arabic version of international index of erectile function (IIEF)

Interventions/Control_2

one group of the PADAM patients will recieve tribulus terristrus 3 times daily for 3 months with follow up of PSA / liver enzymes/ testosterone/ international prostate symptoms score (IPSS)/ validated Arabic version ofinternational index of erectile function (IIEF)

Interventions/Control_3

Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

72 years-old >=

Gender

Male

Key inclusion criteria

PADAM patients with erectile dysfunction and
lower urinary tract symptoms

Key exclusion criteria

1)PADAM patients without erectile dysfunction and low libido
2)PADAM patients with major systemic illness, smoking, drug addict, alcohol abuse

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name sameh fayek

Organization

cairo university

Division name

Andrology & STDs

Zip code


Address

Al-Saray Street, El Manial Cairo-11956-Egypt

TEL

01227109309

Email

samehfayek@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Sameh Fayek

Organization

Cairo University

Division name

Andrology department

Zip code


Address

Al-Saray Street, El Manial Cairo-11956-Egypt

TEL

01227109309

Homepage URL

http://scholar.cu.edu.eg/sfayek/

Email

samehfayek@kasralainy.edu.cu.eg


Sponsor or person

Institute

cairo university

Institute

Department

Personal name



Funding Source

Organization

cairo university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 08 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 20 Day

Last follow-up date

2018 Year 03 Month 29 Day

Date of closure to data entry

2018 Year 03 Month 29 Day

Date trial data considered complete

2018 Year 03 Month 29 Day

Date analysis concluded

2018 Year 04 Month 05 Day


Other

Other related information



Management information

Registered date

2016 Year 07 Month 08 Day

Last modified on

2018 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026592


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name