Status:
COMPLETED
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
Lead Sponsor:
Viramal Limited
Conditions:
Endometriosis
Eligibility:
FEMALE
18-42 years
Phase:
PHASE2
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 singl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03352076
Start Date
December 28 2017
End Date
May 26 2020
Last Update
June 12 2020
Active Locations (1)
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1
Ospedale L. Sacco - Milan-Obgyn Unit
Milan, Italy, 20157