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. - VML-0501-001

VIRAMAL LIMITED0 个研究点目标入组 24 人开始时间: 2020年11月4日最近更新: 2020年11月9日

适应症

试验速览

暂无简介。

•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.

发起方