UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the usefulness of testosterone cream for Late Onset Hypogonadism syndrome
Title of the study (Brief title)	Examination of the usefulness of testosterone cream for LOHsyndrome
Region	Japan

Condition
Condition	LOH Syndrome
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main purpose of this study is to examine the effectiveness of testosterone replacement therapy (TRT) using AndroForte, a cream formulation as a treatment for LOH syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in AMS score at the start of treatment and after 12 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	AndroForte2 AndroForte5
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) AMS (Aging Male Symptom Scale) is 27 points or more 2) 12.5 pg / ml or less by free testosterone (RIA method) 3) Male patients aged 20 years or older at the time of consent acquisition 4) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will 5) Outpatient
Key exclusion criteria	1) Cases in which prostate specific antigen exceeds 4.0 ng / mL and the presence of prostate cancer can not be denied. 2) No treatment When the presence of severe sleep apnea syndrome is suspected. (Excluding examples of positive pressure ventilation therapy) 3) When hemoglobin has polycythemia of 18 g / dL or more 4) Cases in which severe cardiovascular lesions are suspected by echocardiography. 5) In addition, patients who are deemed inappropriate as researchers by the research director
Target sample size	200

Research contact person
Name of lead principal investigator	Shinichi Hisasue
Organization	Chibanisi-General Hospital
Division name	Urology
Address	107-1,Kanegasaku,Matsudo-shi,Chiba,270-2251,japan
TEL	047-384-8111
Email	tiken@chibanishi-hp.or.jp

Public contact
Name of contact person	Shinichi Hisasue
Organization	Chibanisi-General Hospital
Division name	Urology
Address	107-1,Kanegasaku,Matsudo-shi,Chiba,270-2251,japan
TEL	047-384-8111
Homepage URL
Email	tiken@chibanishi-hp.or.jp

Sponsor
Institute	Chibanisi-General Hospital
Institute
Department

Funding Source
Organization	Chibanisi-General Hospital
Organization
Division
Category of Funding Organization	Other
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	2017 Year 10 Month 13 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 07 Month 07 Day
Anticipated trial start date	2016 Year 09 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 13 Day
Last modified on	2017 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033750