Health Condition 1: N00-N99- Diseases of the genitourinary system
Conditions
Interventions
Intervention1: Tablet Erectisity: You have to take 1 tablet of once daily 1 hour after dinner and 1 hour before bed time for 4 weeks
Subject will receive study treatment for 28 days
Control Interve
Sponsors
Usha Enterprise
Eligibility
Inclusion criteria
Inclusion criteria: Male patients 25 to 65 years of age (inclusive of both) involved in a stable heterosexual relationship of >6 months Subjects who have scored 11 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening visit. Subjects willing to participate in clinical trial and who have read understood and signed informed consent form. Subjects willing to make all required study visits
Exclusion criteria
Exclusion criteria: Subjects having anatomical abnormalities of the penis. Patients that have undergone radical prostatectomy, spinal cord injury, or any other surgery of urogenital organs. Subjects with severe form of sexual dysfunction as evidenced by at least one of the following conditions, An International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is less than 11 and greater than 25 at screening Subjects with prior ineffective treatment with (or non-responder to) any PDE5 Inhibitor or underwent treatment for promoting spermatogenic fertility in last 3 months Subjects with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator Presence of any drug or therapy that may have relation with ED and sexual dysfunction (nitrates, anti-androgens, chemotherapy agents, radiotherapy, etc.) Subjects with history or presence of significant alcoholism or drug abuse within the past 1 year. Presence or history of any of the following disorders/disease within the past 3 months, that might have impact on the clinical trial as per the investigator discretion- A)cardiovascular, b) cerebrovascular, c) dermatological, d) gastrointestinal, e) gynecological, f) hematological, g) hepatic, h) malignancy, i) metabolic, j) musculoskeletal, k) neurological, l) psychiatric, m) thyroid n) psychological, o) renal, p) respiratory, q) venereal, r) any other major disorders Subjects with history or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco/nicotine products more than 10 times per day. Known cases of hypothyroidism, hyperprolactinaemia or low testosterone levels Significant hepatic or renal function impairment (hepatic enzymes >1.5 times the upper limit of normal and/or serum creatinine >1.8 mg per 100 ml) during screening Uncontrolled diabetes mellitus Hypertension ( >170/110 mm Hg), hypotension ( Patients receiving hormonal treatment, antidepressants, antipsychotics, or any other psychoactive drugs. Known cases of varicocele, hydrocele, HIV/AIDS, Hepatitis C and B, Cancer and major debilitating diseases Known hypersensitivity to ingredients used in study drugs 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Change from Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 4 [Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.]Timepoint: Visit 2 - Baseline Visit 3 - Interim Visit 4 - End of Treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the Change from Baseline in the International Index of Erectile Function - Total Domain (IIEF-TD) at Week 4 [ IIEF includes 15 questions and addresses the 5 sub-domains of Erectile function, Intercourse satisfaction, Orgasm function, Sexual desire, and Overall satisfaction. The IIEF-total domain is the sum of sub-domains. Lower scores indicate severe erectile dysfunction, while higher scores indicate less erectile dysfunction.] To assess the Response to Global Efficacy QuestionsTimepoint: Visit 2 - Baseline Visit 3 - Interim Visit 4 - End of Treatment | — |
Countries
India
Contacts
Public ContactDr Manish Rajak
Innvocept Global Solutions Pvt Limited
Outcome results
None listed