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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

Trial Profile

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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Oct 2018

At a glance

  • Drugs Danazol (Primary) ; Danazol
  • Indications Endometriosis
  • Focus Pharmacokinetics
  • Sponsors Viramal
  • Most Recent Events

    • 27 Sep 2018 Planned number of patients changed from 24 to 34.
    • 20 Jun 2018 Planned End Date changed from 1 Jul 2018 to 1 Mar 2019.
    • 20 Jun 2018 Planned primary completion date changed from 1 May 2018 to 1 Dec 2018.
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