Ospedale L. Sacco - Milan-Obgyn Unit
Milan, 20157, Italy
NCT Number: NCT03352076
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.
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Notify Me18 year–42 year
Female
Interventional
Phase 2
Milan, 20157, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
If any of the following criteria apply, the subject MUST NOT be admitted/continue the study trial.
The subject:
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
Time frame: 6 months
Concentration in serum and peritoneal fluid
Time frame: 6 months
Concentration in endometrial tissue found outside the uterus
Time frame: 6 months
Concentration in endometrium tissue
Time frame: 6 months
Concentration in myometrium tissue
Viramal Limited
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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