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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Health Ever Bio-Tech Co., Ltd..
Recruitment status was  Recruiting
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

November 17, 2009
December 13, 2011
December 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01016340 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Male Oligoasthenospermia
Drug: MCS
MCS-5 Softgel 5 mg
  • 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
    Intervention: Drug: MCS
  • Placebo Comparator: Placebo
    Group 4: Placebo for 16 weeks
    Intervention: Drug: MCS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
116
June 2013
December 2012   (final data collection date for primary outcome measure)

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.
Male
20 Years and older
Yes
Contact: Fu-Feng Kuo +886-2-25790062 ff.kuo@hebiotech.com
Taiwan
 
NCT01016340
MCS-5-TWN-a
No
Health Ever Bio-Tech Co., Ltd.
Health Ever Bio-Tech Co., Ltd.
Not Provided
Not Provided
Health Ever Bio-Tech Co., Ltd.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP