Phase
Condition
Impotence
Male Hormonal Deficiencies/abnormalities
Infertility
Treatment
N/AClinical Study ID
Ages 20-65 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Type 1 or 2 diabetes,blood glucose controlled well, no effective with oral PDE-5i
Have a consistent partner who is willing to engage in sexual activity more than twiceper month during the study
Males, age 20-65 years
IIEF-5 score is under 16
Penile arterial insufficiency or venous leakage (doppler): peak systolic velocity(PSV) <25 cm/sec, or peak systolic velocity(PSV)>25 cm/sec, end-diastolic velocity(EDV)> 5cm/sec, resistance index(RI)<0.75
HbA1c is between 6.5%-10%
Physical examination with no abnormalities
Willing to consent to participate in the study follow-up
Willing to limit alcohol intake eliminate use of recreational drugs for sexualencounters.
Exclusion
Exclusion Criteria:
Severe cardiovascular disease (angina, arrhythmia, cardiac failure, stroke), kidneyfailure, respiratory failure; history of malignancy
Positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis CVirus (HCV) syphilis test
Testosterone level is less than 200ng/dL
Serum AST/ALT >3upper limit of normal or creatinine >1.5upper limit of normal
HbA1c exhibit greater than 10%
In the investigators judgment, with clinical significance of penis abnormalities, orhas received penile prosthesis implantation surgery
Patients partner is trying to conceive during the trial period
Exposure to any investigational drug or procedure within 1 month prior to study entryor enrolled in a concurrent study that may confound results of this study
Unwilling and/or not able to give written informed consent
Study Design
Connect with a study center
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
ChinaActive - Recruiting

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