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

NCT ID: NCT03352076

Last Updated: 2020-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-28
• Study Completion Date: 2020-05-26

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Danatrol

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

Group Type: ACTIVE_COMPARATOR

Oral Danatrol

Intervention Type: DRUG

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

Vaginal Danazol

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

Group Type: EXPERIMENTAL

Vaginal Danazol

Intervention Type: DRUG

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

Interventions

Vaginal Danazol

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

Intervention Type: DRUG

Oral Danatrol

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Viramal Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simona Fiore, Dr

Role: STUDY_DIRECTOR

Viramal Limited

Locations

Ospedale L. Sacco - Milan-Obgyn Unit

Milan, , Italy

Countries

Italy

Other Identifiers

VML-0501-001

Identifier Type: -

Identifier Source: org_study_id