Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia

Official Title: “A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia (MCS_MOS)”

This is a phase II randomized, double-blind, placebo-controlled study where eligible subfertile male subjects (age 20 years).

Intervention(s) in this Clinical Trial

• Drug: MCS
  • MCS-5 Softgel 5 mg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: MCS-5
  • Group 1: MCS-5 5 mg/day for 16 weeks;Group 2: MCS-5 10 mg/day for 16 weeks;Group 3: MCS-5 20 mg/day for 16 weeks
• Placebo Comparator: Placebo
  • Group 4: Placebo for 16 weeks

Primary Measures

• To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment
  • Time Frame: 16 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Male subjects who are 20 years old or older
• 2. Subjects who are diagnosed as idiopathic oligoasthenospermia
• 3. Subjects who have a normal baseline hormone profile
• 4. Subjects who were not able to impregnate female partners in the past 12 months under an active and unprotected sexual life
• 5. Subject's female partner has no endocrine or genital obstructive disorders and is capable of impregnation.
• 6. Subjects who have an acceptable baseline liver function
• 7. Subjects who have a normal baseline renal function.

Exclusion Criteria:

• 1. Subjects who have been diagnosed as male infertility for more than 5 years.
• 2. Subjects who have a baseline semen white blood cell count of 1*106/mL.
• 3. Subjects who have genital/seminal tract obstruction, infection, inflammation or anatomic abnormalities.
• 4. Subjects whose female partner has been diagnosed as infertility of any kind.
• 5. Male infertility that is associated with hormonal deficiency/imbalance, poor nutrition, congenital/chromosomal disorders, erectile dysfunction, or psychological disorders.
• 6. Subjects who plan to undergo artificial insemination of any kind within the study period.
• 7. Subjects who have been treated with chemotherapy, pelvic irradiation or major pelvic surgery
• 8. Subjects who will undergo any invasive procedures within the study period
• 9. Subjects who will undergo any chemotherapy or radiotherapy of any kind during the study period.
• 10. Subjects who can not or are not willing to undergo the two-week wash-out period for any reasons.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Health Ever Bio-Tech Co., Ltd. Industry

Overall Clinical Trial Officials and Contacts

Overall Contact: Fu-Feng Kuo +886-2-25790062 ff.kuo@hebiotech.com

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016340

Study ID Number: MCS-5-TWN-a

ClinicalTrials.gov Identifier: NCT01016340

Health Authority: United States: Institutional Review Board