NCT03352076

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

A Comparative, Open-Label, Randomized, Parallel Group Study to Determine Intraperitoneal Fluids, Tissue, and Serum Concentrations of VML-0501 Following Five Days of Daily Vaginal Applications of Single Dose of VML-0501 (100 mg Danazol), in Comparison to Five Days of Danazol Treatment Administered as an Oral Capsules (Danatrol) at a Daily Dose of 600 mg, in Two Groups of Twelve Each Consisting of Women With Suspected or Confirmed Endometriosis and Scheduled for Laparoscopy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Viramal Limited · Industry
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

A Comparative, Open-Label, Randomized, Parallel Group Study to determine Intraperitoneal fluids, tissue, and serum concentrations of VML-0501 following five days of daily vaginal applications of single dose of VML-0501 (100 mg Danazol), in comparison to five days of Danazol treatment administered as an oral capsule (Danatrol) at a daily dose of 600 mg, in two groups of twelve each consisting of women with suspected or confirmed endometriosis and scheduled for laparoscopy.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Vaginal Danazol	Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
DRUG	Oral Danatrol	Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

Timeline

• Start date: 2017-12-28
• Primary completion: 2019-10-24
• Completion: 2020-05-26
• First posted: 2017-11-24
• Last updated: 2020-06-12

Locations

1 site across 1 country: Italy