Clinical trial NCT03352076: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Danazol
Lead sponsor: Viramal Limited
Sponsor class: INDUSTRY
First posted: 2017-11-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Danazol concentration
timeFrame: 6 months
Secondary outcomes:
measure: Danazol concentration
timeFrame: 6 months
Other outcomes:
measure: Danazol concentration
timeFrame: 6 months
measure: Danazol concentration
timeFrame: 6 months
Locations:
city: Milan
country: Italy
facility: Ospedale L. Sacco - Milan-Obgyn Unit
Study officials:
affiliation: Viramal Limited
name: Simona Fiore, Dr
role: STUDY_DIRECTOR
References: