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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Ospedale L. Sacco - Milan-Obgyn Unit
Milan, Italy
Danazol concentration
Concentration in serum and peritoneal fluid
Time frame: 6 months
Danazol concentration
Concentration in endometrial tissue found outside the uterus
Time frame: 6 months
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