Effect of Semenax Capsules versus placebo on semen characteristics of males with normal semen volume and low semen volume

Phase 2

• Conditions: Health Condition 1: null- Low Semen Volume

• Registration Number: CTRI/2011/09/001995
• Lead Sponsor: eading Edge Marketing

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 96

Inclusion Criteria

Men with hypospermia (semen volume lower than 2ml) or normospermia (semen volume 2-5.5ml) on at least two semen analyses)

Men with normozoospermia (sperm concentration 20x106 /ml

Men with mild oligospermia (sperm concentration10-19.99x106/ml or moderate oligospermia (sperm concentration 4-10x106/ml)

Men with normal to subnormal levels of sperm motility and sperm morphology

Men willing to maintain a consistent abstinence period of 2 to 7 days each time before producing semen samples and comply with other semen collection procedures

Exclusion Criteria

1.Aspermia (no semen)

2.Absence of Fructose /low fructose (13 µmol per ejaculate)

3.ph7.2 or 8.0

4.Presence of red blood cells (hemospermia)

5.Excessive leucocytes or leucospermia (peroxidase positive cells1x106 /ml)

6.Severe impairment of ejaculate volume or sperm concentration or sperm motility or sperm morphology

7.Ejaculate volume5.5 ml (Includes hyperspermia i.e 7 ml of ejaculate volume)

8.Moderate impairment occurring in more than two sperm parameters: sperm concentration, sperm morphology and sperm motility

9.Neurological disorders such as multiple sclerosis, , demyelization disease, tumors, degenerative conditions etc

10.Presence of diabetic neuropathy or complications, use of insulin for glycemic control, duration of diabetes over five years from detection

11.Untreated or uncontrolled hypertension

12.Inflammatory disorders, infections or obstruction of the genital tract

13.Congenital anomalies (spina bifida, spinal dysraphism , congenital bilateral/ unilateral absence of the vas deferens )

14.History of trauma to the pelvic organs or spinal cord injury

15.Surgical history of radical prostatectomy, retroperitoneal lymphadenectomy, bladder neck surgery, pelvic surgery, spinal cord surgery, vasectomy

16. History of mumps orchitis within 3 years of screening

17.History of Cryptorchidism

18.Complete absence of ejaculation (anejaclation), anorgasmia or dysorgasmia

19.Known or suspected cases of.Klinefelter?s syndrome or Kartagener?s syndrome

20.Clinical suspicion of benign prostratic hyperplasia or varicocele

21.Recent history of a major systemic illness

22.Occurrence of febrile illness (temperature over 102º F) within 3 months before screening/ semen sample collection

23.Drug exposure known to affect sperm characteristics, within three months of the first semen analysis. (Refer list of prohibited medications)

24.Illnesses (including psychiatric illnesses) that received (within one month of screening) or require treatment with drugs known to affect sexual function (Refer list of prohibited medications)

25.Known cases of HIV ,AIDS or recent cases of sexually transmitted diseases

26.Infertility treatment or assisted reproductive procedures

27.Clinically significant laboratory abnormality at screening

28.Any other condition which in the opinion of the investigator may affect the evaluations of the study

29.BMI 30 kg/m2

30.Moderate to heavy alcohol consumption (more than 40 to 80 grams/ 3.5 to 7 standard drinks, per day)

31. Excessive smoking (more than 10 cigarettes per day)

32.Substance abuse (eg heroin, methadone, marijuana etc)

33.Occupational or environmental exposure to risk factors for male reproductive system (eg. Chronic exposure to heat, ionizing radiation, heavy metals like lead cadmium, certain pesticides like dibromochloropropane, aromatic solvents, driving for prolonged intervals, frequent sauna baths etc)

34.Participation in a clinical study 2 months prior to screening

35.Known hy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Semen ejaculate volumeTimepoint: Day 0, Day 60

Secondary Outcome Measures

Name	Time	Method
1. sperm concentration, sperm motility and sperm morphology <br>2. International index of erectile function - Erectile function<br>3. Grade of Orgasm intensity<br>4. Global assessment by the investigatorTimepoint: Day 0, Day 30, Day 60 and End of the treatment visit, 20 days apart from End of the treatment.