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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352076
• Other study ID #: VML-0501-001
• Status: Completed
• Phase: Phase 2
• Start date: December 28, 2017
• Est. completion date: May 26, 2020

Study information

• Verified date: June 2020
• Source: Viramal Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 26, 2020
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Vaginal Danazol
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
• Oral Danatrol
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol

Locations

Country	Name	City	State
Italy	Ospedale L. Sacco - Milan-Obgyn Unit	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Viramal Limited

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Danazol concentration	Concentration in endometrium tissue	6 months
Other	Danazol concentration	Concentration in myometrium tissue	6 months
Primary	Danazol concentration	Concentration in serum and peritoneal fluid	6 months
Secondary	Danazol concentration	Concentration in endometrial tissue found outside the uterus	6 months