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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: Oral Danatrol; Drug: Vaginal Danazol

• Registration Number: NCT03352076
• Lead Sponsor: Viramal Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-24
• Study Start: 2017-12-28
• Primary Completion: 2019-10-24
• Study Completion: 2020-05-26
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Danatrol	Oral Danatrol	200 mg orally TDS (600 mg daily) for 5-7 days
Vaginal Danazol	Vaginal Danazol	100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose

Primary Outcome Measures

Name	Time	Method
Danazol concentration	6 months	Concentration in serum and peritoneal fluid

Secondary Outcome Measures

Name	Time	Method
Danazol concentration	6 months	Concentration in endometrial tissue found outside the uterus

Trial Locations

Locations (1)

Ospedale L. Sacco - Milan-Obgyn Unit; 🇮🇹 Milan, Italy