A Comparative, Open-Label, Controlled, monocentric study to determine the serum and Intraperitoneal fluids concentrations of vaginal applications of danazol (100mg/die) in comparison to administration of danazol oral capsules (600mg/die) in groups of women with suspected or confirmed endometriosis and scheduled for laparoscopy.
- Conditions
- endometriosisMedDRA version: 20.0Level: LLTClassification code 10014789Term: Endometriosis, site unspecifiedSystem Organ Class: 100000004872Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2017-000988-32-IT
- Lead Sponsor
- VIRAMAL LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 24
The subject must:
•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 with signs and symptoms of 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 with signs and symptoms of endometriosis within first 10 days of her cycle.
•Have a body mass index (BMI) < 32 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of:<br>- Concentrations in serum <br>- Concentrations in peritoneal fluid.<br>;Secondary Objective: Secondary study outcome:<br>- Concentration in endometrial tissue found outside the uterus (Lesion tissue) <br>;Primary end point(s): To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of Concentrations in serum, concentrations in peritoneal fluid.<br>;Timepoint(s) of evaluation of this end point: 5 - 7 days treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): To assess the bioavailability of VML-0501 in comparison to oral Danazol in terms of concentration in endometrial tissue found outside the uterus (Lesion tissue) <br>;Timepoint(s) of evaluation of this end point: 5-7 days treatment