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

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).

Study Overview

• Status: Terminated
• Conditions: Male Oligoasthenospermia
• Intervention / Treatment: Drug: MCS

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fu-Feng Kuo; Phone Number: +886-2-25790062; Email: ff.kuo@hebiotech.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare changes in total motile sperm (TMS) between groups from baseline to 16 weeks after treatment	16 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: November 17, 2009
• First Submitted That Met QC Criteria: November 18, 2009
• First Posted (Estimated): November 19, 2009

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: MCS; Male Oligoasthenospermia
• Other Study ID Numbers: MCS-5-TWN-a