UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	sameh fayek
Organization	cairo university
Division name	Andrology & STDs
Address	Al-Saray Street, El Manial Cairo-11956-Egypt
TEL	01227109309
Email	samehfayek@hotmail.com

Public contact
Name of contact person	Sameh Fayek
Organization	Cairo University
Division name	Andrology department
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
Institute	cairo university
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026592