Clinical study of SHL 1046 Tablet in erectile dysfunctio

Phase 2

Conditions: Health Condition 1: N529- Male erectile dysfunction, unspecified

Registration Number: CTRI/2018/12/016697

Lead Sponsor: Savesta Lifesciences Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male subjects aged 21-50 years suffering from ED.

2.Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit.

3.Subjects should be in an active stable sexual relationship for the entire duration of study

4.Subjects willing to participate in clinical trial and who have read understood and signed informed consent form.

5.Subjects willing to make all required study visits

Exclusion Criteria

1.Subjects having anatomical abnormalities of the penis.

2.Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs.

3.Subjects with severe form of sexual dysfunction

4.Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year.

5.Subjects with any clinically significant laboratory or ECG findings during screening.

6.Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs.

7.Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases

8.Known hypersensitivity to ingredients used in study drugs

9.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in Erectile function of penis on Erectile function subscale of IIEF Questionnaire from baseline to end of the study <br/ ><br> <br/ ><br>2.Change in Sexual desire/ Libido (IIEF questionnaire) from baseline to end of the study <br/ ><br>Timepoint: Screening Visit (up to -14 days), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) <br/ ><br>2.Change in Sexual desire/ Libido (IIEF questionnaire) from baseline to end of the study <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Change in hardness of penis, orgasmic function, intercourse satisfaction and overall satisfaction of IIEF Questionnaire <br/ ><br>2.Change in male sexual health, quality of penile erection, sexual encounter profile <br/ ><br>3.Change in serum total testosterone <br/ ><br>4.Change in intra-vaginal ejaculation latency time (IELT) <br/ ><br>5.Change in global assessment for overall improvement <br/ ><br>6.Percentage of participants with adverse events <br/ ><br>7.Changes in the vitals, Tolerability of study drugs, laboratory parameters <br/ ><br>Timepoint: Screening Visit (up to -14 days), Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) <br/ ><br>