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 Endo

• Status: Completed
• Trial end date: 2020-05-26
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Viramal Limited
• Treatments: Danazol

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.