Efficacy and Safety of MCS-5 in Treating Male Oligoasthenospermia

NCT01016340 | Terminated Phase 2

• 1 other identifier: MCS-5-TWN-a
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Male Oligoasthenospermia

Keywords

Male Oligoasthenospermia; MCS

Outcome Measures

Primary Outcomes (1)

• To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment

  16 weeks

Study Arms (2)

MCS-5

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Group 4: Placebo for 16 weeks

Drug: MCS

Interventions

MCS DRUG

MCS-5 Softgel 5 mg

MCS-5; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Health Ever Bio-Tech Co., Ltd.: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2009
• First Posted: November 19, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: December 21, 2023

Record last verified: 2023-12

Locations

TW (1)