vaginal danazol (VML-0501) / Viramal - LARVOL DELTA

A Comparative, Open-Label, Controlled, monocentric study to determine the serum and Intraperitoneal fluids concentrations of vaginal applications of danazol (100mg/die) in comparison to administration of danazol oral capsules (600mg/die) in groups of women with suspected or confirmed endometriosis and scheduled for laparoscopy. ¿Studio comparativo, in aperto, controllato, monocentrico volto a... (clinicaltrialsregister.eu) - P2; N=24; Terminated; Sponsor: VIRAMAL LIMITED

Clinical • New P2 trial • Endometriosis • Gynecology

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=30; Completed; Sponsor: Viramal Limited; Active, not recruiting ➔ Completed

Clinical • Trial completion • Endometriosis • Gynecology

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=34; Active, not recruiting; Sponsor: Viramal Limited; Trial completion date: Feb 2020 ➔ Jun 2020

Clinical • Trial completion date • Endometriosis • Gynecology

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=34; Active, not recruiting; Sponsor: Viramal Limited; Trial completion date: Nov 2019 ➔ Feb 2020

Clinical • Trial completion date

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=34; Active, not recruiting; Sponsor: Viramal Limited; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: Viramal Limited; Trial completion date: Jul 2019 ➔ Oct 2019

Trial completion date

"Per vaginam" topical use of hormonal drugs in women with symptomatic deep endometriosis: a narrative literature review. (PubMed, Arch Gynecol Obstet) - "The vaginal route represents a scarcely explored modality for drug administration. High local hormonal concentrations might achieve a greater effect on endometriotic lesions compared with alternative routes. Future studies should focus on the use of the vagina for delivering target therapies particularly in patients with deeply infiltrating rectovaginal lesions."

Clinical • Journal • Review

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: Viramal Limited; Trial completion date: Mar 2019 ➔ Jul 2019; Trial primary completion date: Mar 2019 ➔ Jul 2019

Clinical • Trial completion date • Trial primary completion date

Study to Determine Intraperitoneal,Tissue, Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Single Dose of VML-0501 (100 mg Danazol), in Comparison to Oral Danazol Capsules Daily 600 mg), in Women With Signs and Symptoms of Endometriosis Undergoing Laparoscopy (clinicaltrials.gov) - P2; N=34; Recruiting; Sponsor: Viramal Limited; Trial primary completion date: Dec 2018 ➔ Mar 2019

Clinical • Trial primary completion date