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

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 28, 2017

Primary Completion Date

October 24, 2019

Study Completion Date

May 26, 2020

Conditions
Endometriosis
Interventions
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

Trial Locations (1)

20157

Ospedale L. Sacco - Milan-Obgyn Unit, Milan

All Listed Sponsors
lead

Viramal Limited

INDUSTRY

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 | Biotech Hunter | Biotech Hunter