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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Oral Danatrol; Drug: Vaginal Danazol

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20157
    • Ospedale L. Sacco - Milan-Obgyn Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Provide written (personally signed and dated) informed consent before completing any study-related procedure, which means any assessment or evaluation that would not have formed a part of her normal medical care.
• Be a female who has or is suspected to have endometriosis
• Greater than or equal to 18 years of age and less than 42years.
• Scheduled to undergo laparoscopy.
• According to the local practice the women should sign a specific clause on avoiding pregnancy based on the use of two effective methods for birth control (condom and spermicidal) following 30 days after the last dose/application.
• Be non-pregnant undergoing laparoscopy for confirmed or suspected endometriosis within first 10 days of her cycle.
• Have a body mass index (BMI) < 32 kg/m2

Exclusion Criteria:

If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial.

The subject:

• Is pregnant (if positive-Urine pregnancy test at screening) or lactating;
• Has evidence of drug or alcohol abuse.
• Have used hormonal replacement therapy or Danazol therapy within the past 8 weeks before study entry
• Has any of the following: Epileptic Seizure, Migraine Headache, Angina, Chronic Heart Failure, Obstruction of a Blood Vessel by a Blood Clot, Liver Problems, Kidney Disease, Pregnancy, Combined High Blood Cholesterol and Triglyceride Level, Porphyria
• Undiagnosed abnormal genital bleeding
• Androgen dependant tumour
• Is Allergic to anabolic androgenic steroid.
• Smoker.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Danatrol; 200 mg orally TDS (600 mg daily) for 5-7 days	Drug: Oral Danatrol; Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Experimental: Vaginal Danazol; 100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose	Drug: Vaginal Danazol; Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Danazol concentration	Concentration in serum and peritoneal fluid	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Danazol concentration	Concentration in endometrial tissue found outside the uterus	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Danazol concentration	Concentration in endometrium tissue	6 months
Danazol concentration	Concentration in myometrium tissue	6 months

Collaborators and Investigators

• Sponsor: Viramal Limited
• Investigators: Study Director: Simona Fiore, Dr, Viramal Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2017
• Primary Completion (Actual): October 24, 2019
• Study Completion (Actual): May 26, 2020

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Danazol
• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Danazol
• Other Study ID Numbers: VML-0501-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No