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Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia (MCS_MOS)

This study is currently recruiting participants.
Verified December 2011 by Health Ever Bio-Tech Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01016340
First received: November 17, 2009
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Male Oligoasthenospermia
 Drug: MCS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Further study details as provided by Health Ever Bio-Tech Co., Ltd.:

Primary Outcome Measures:
  • To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: December 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: MCS
MCS-5 Softgel 5 mg
Placebo Comparator: Placebo
Group 4: Placebo for 16 weeks
 Drug: MCS
MCS-5 Softgel 5 mg

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016340

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

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Hong-chiang Chang, M.D.         hongchiangchang@ntu.edu.tw    
Principal Investigator: Hong-Chiang Chang, M.D.            
Sponsors and Collaborators
Health Ever Bio-Tech Co., Ltd.
  More Information

No publications provided

Responsible Party: Health Ever Bio-Tech Co., Ltd.
ClinicalTrials.gov Identifier: NCT01016340     History of Changes
Other Study ID Numbers: MCS-5-TWN-a
Study First Received: November 17, 2009
Last Updated: December 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Health Ever Bio-Tech Co., Ltd.:
Male Oligoasthenospermia
MCS

ClinicalTrials.gov processed this record on May 19, 2013