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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

Primary Purpose

Endometriosis

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Vaginal Danazol

Oral Danatrol

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Danazol

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Ospedale L. Sacco - Milan-Obgyn Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oral Danatrol

Vaginal Danazol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Danazol concentration

Concentration in serum and peritoneal fluid

Secondary Outcome Measures

Danazol concentration

Concentration in endometrial tissue found outside the uterus

Full Information

NCT ID

NCT03352076

First Posted

November 17, 2017

Last Updated

June 11, 2020

Sponsor

Viramal Limited

1. Study Identification

Unique Protocol Identification Number

NCT03352076

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 28, 2017 (Actual)

Primary Completion Date

October 24, 2019 (Actual)

Study Completion Date

May 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Viramal Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endometriosis

Keywords

Danazol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Danatrol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Vaginal Danazol

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vaginal Danazol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oral Danatrol

Intervention Description

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

Primary Outcome Measure Information:

Title

Danazol concentration

Description

Concentration in serum and peritoneal fluid

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Danazol concentration

Description

Concentration in endometrial tissue found outside the uterus

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Danazol concentration

Description

Concentration in endometrium tissue

Time Frame

6 months

Title

Danazol concentration

Description

Concentration in myometrium tissue

Time Frame

6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simona Fiore, Dr

Organizational Affiliation

Viramal Limited

Official's Role

Study Director

Facility Information:

Facility Name

Ospedale L. Sacco - Milan-Obgyn Unit

City

Milan

ZIP/Postal Code

20157

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

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