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This is a randomized, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy and safety of YN001 in patients with atherosclerotic cardiovascular and cerebrovascular diseases and erectile dysfunction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YN001 20mg Dose + 5% glucose injection | Active Comparator | Specified dose on specified Days |
|
| 5% glucose injection | Placebo Comparator | Specified dose on specified Days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YN001 20mg Dose + 5% glucose injection | Drug | The treamtment group was given YN001 20 mg, once a week (QW), cumulative administration for 12 weeks (about 3 months) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in IIEF-EF (Questions 1-5 and 15 in the IIEF scale) score at Week 13 visit; | 12 weeks | |
| Change From Baseline in Carotid Artery Intima-media Thickness (IMT) by Peripheral Ultrasound at Week 13 Visit. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event (AE)/serious adverse event (SAE); | 16 weeks |
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Inclusion Criteria:
1) At least 4 attempts at sexual intercourse during the run-in period; 2) Has a failure rate of ≥ 50% of attempts to intercourse (failure to intercourse is defined as having at least one of the three questions answered on the SEP); 3) IIEF-EF score ≥ 11 and ≤ 25.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Zhang | Contact | 861082599080 | zhangjing@innovmedicine.com |
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| 5% glucose injection | Other | The control group was given placebo once a week (QW), cumulative administration for 12 weeks (about 3 months) |
|
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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