Composition for Treating Spermatogenesis and Semen Disorders / FPT-20

NCT05399212 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Therapy to spermatogenesis
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

Research to develop a new, natural-derived formulation that eliminates inflammatory tissue and regenerates new tissue of the lobules, epithelium of the tubules, and connective tissue surrounding the seminiferous tubules in the testes. It restores Leydig cells and Sertoli cells' function (because the inflamed testicles were unable to perform spermatogenesis).

Conditions

Spermatogenesis and Semen Disorders

Keywords

Spermatogenesis; Male infertility; Orchitis; Mumps virus; Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Use FPT-20 drugs to increase sperm count in semen.

  Count the number of sperm in the semen.

  180 days

Study Arms (1)

FPT-20

EXPERIMENTAL

FPT-20 should be used regularly (\>6 to 12 months) until the therapeutic purpose is achieved.

Drug: FPT-20

Interventions

FPT-20 DRUG

FPT-20 should be used regularly, the daily maintenance dose is 1 tablet once a day(\>6 to 12 months) until the therapeutic purpose is achieved.

FPT-20

Eligibility Criteria

• Age: 25 Years - 40 Years
• Gender Eligibility Details: Carries the sex chromosome gene XY
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The selected person has evidence of spermatogenesis disorder, no sperm, and weak sperm that do not meet the standards in terms of quantity and quality.
• There are signs of orchitis.
• Accepting patients with other comorbidities such as metabolic diseases, congenital or acquired immunodeficiency, HIV/AIDS, HBV, HCV, and Tuberculosis.

You may not qualify if:

• Do not select patients with advanced cancer.

Sponsors & Collaborators

• Trieu, Nguyen Thi, M.D.: lead
• TRAN MINH DUC, MD: collaborator

Study Sites (2)

Saigon Biopharma LLC

Wilmington, Delaware, 19801-6601, United States

Location

Saigon Biopharma Company Limited

Hồ Chí Minh, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Infertility, Male; Orchitis; Hypogonadism

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Testicular Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Nguyen Thi Trieu, Dr.

  Trieu, Nguyen Thi, M.D.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: The number of infertile people after recruitment was divided into 2 groups. * Spermatogenesis. * Male infertility group due to lack of sperm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: The number of infertile people after recruitment was divided into 2 groups. * Spermatogenesis. * Male infertility group due to lack of sperm.

Study Record Dates

• First Submitted: May 21, 2022
• First Posted: June 1, 2022
• Study Start: October 29, 2020
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1); VN (1)