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

NCT03352076 | Completed Phase 2

• 1 other identifier: VML-0501-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Danazol

Outcome Measures

Primary Outcomes (1)

• Danazol concentration

  Concentration in serum and peritoneal fluid

  6 months

Secondary Outcomes (1)

• Danazol concentration

  6 months

Other Outcomes (2)

• Danazol concentration

  6 months

• Danazol concentration

  6 months

Study Arms (2)

Oral Danatrol

ACTIVE COMPARATOR

200 mg orally TDS (600 mg daily) for 5-7 days

Drug: Oral Danatrol

Vaginal Danazol

EXPERIMENTAL

100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose

Drug: Vaginal Danazol

Interventions

Vaginal Danazol DRUG

Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

Vaginal Danazol

Oral Danatrol DRUG

Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

Oral Danatrol

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viramal Limited: lead

Study Sites (1)

Ospedale L. Sacco - Milan-Obgyn Unit

Milan, 20157, Italy

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Danazol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Simona Fiore, Dr

  Viramal Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 24, 2017
• Study Start: December 28, 2017
• Primary Completion: October 24, 2019
• Study Completion: May 26, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)