Nanopharmaceutics Announces NanoDOX® Hydrogel will be Tested in Patients with Genital Mycoplasmas in The University of Western Australia Phase II Clinical Trial
TRON Group Inc (OTCMKTS:TGRP)
ALACHUA, FL, UNITED STATES, May 9, 2025 /EINPresswire.com/ -- Nanopharmaceutics, Inc., a clinical-stage pharmaceutical development company, announced NanoDOX® 1% Doxycycline Monohydrate hydrogel with oral doxycycline will be tested in male partners with Genital Mycoplasmas in The University of Western Australia Clinical Trial "Efficacy of treating asymptomatic infections to restore fertility: The RESETTER Study: A prospective, single-centre, multi-site clinical trial of the effect of a combined partner treatment program for clearance of asymptomatic genital Mycoplasmas on unexplained fertility and clinical pregnancy rates " (Registration number: ACTRN12624001180505). The primary objective of the phase 2 study will be to measure the change in rate of clinical pregnancy at three months post-treatment in couples treated for Genital Mycoplasma colonization. The Principal Investigator is A/Prof. Matthew Payne, a Principal Research Fellow at The University of Western Australia, Obstetrics and Gynaecology. The study will recruit 440 patients and run through to the end of 2027.Over 200 couples will be recruited in the ‘RESETTER’ study, which aims to reduce the rate of unexplained infertility in couples attending Concept Fertility and City Fertility who test positive for Genital Mycoplasmas. Both partners will be treated with antibiotics, with the male partner using NanoDOX® in combination with oral doxycycline 100mg tablets taken orally, twice daily for seven days. In this trial, NanoDOX® 1% Doxycycline Monohydrate hydrogel will be used for the treatment of penile colonization by Ureaplasma urealyticum and Mycoplasma hominis. Doxycycline is a broad-spectrum antibiotic that is effective against Gram positive and negative pathogens, as well as Genital Mycoplasmas, Spirochaetes and some parasites. The natural conception rate in treated couples will be documented in the three months following treatment and compared with this in couples who were negative for Genital Mycoplasmas. The addition of topical NanoDOX® treatment in males is based on the results of the recent successful Step Up trial for prevention of Bacterial Vaginosis recurrence in women by including male partner treatment (2% clindamycin cream.)
Only two clinical trials have explored the treatment of Genital Mycoplasmas in male partners, demonstrating highly significant improvements in sperm parameters. These studies also indicate a notable increase in successful pregnancies following treatment.
About Nanopharmaceutics, Inc.
Nanopharmaceutics, Inc. is a clinical-stage specialty pharmaceutical company developing oral, topical, and injectable products for cancer, central nervous system (CNS) disorders, and infectious diseases. Nanopharmaceutics, Inc. is a wholly-owned subsidiary of TRON Pharmaceuticals, Inc. (OTC:TGRP)
About The University of Western Australia
The University of Western Australia (UWA) is a public research university established in 1911 by an Act of the Parliament of Western Australia.
As the State's leading university, it has actively led the conversation, bringing passion, energy, and insight - generating remarkable, life-changing outcomes that help solve the challenges of our time. UWA is a proud member of the internationally recognised Group of Eight, a coalition of Australia's leading research-intensive universities. Through its partnerships, high-impact research, innovative courses, and commitment to student experience, UWA has achieved its status as a world top 100 university (QS 2025).
James D Talton
Alchem Laboratories Corp.
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