NCT03352076已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Danazol concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Oral Danatrol
Active Comparator
200 mg orally TDS (600 mg daily) for 5-7 days
干预措施: Oral Danatrol (Drug)
Vaginal Danazol
Experimental
100 mg of Danazol Cream to be applied vaginally for 5-7 days on a single daily dose
干预措施: Vaginal Danazol (Drug)
结局指标
主要结局
Danazol concentration
时间窗: 6 months
Concentration in serum and peritoneal fluid
次要结局
- Danazol concentration(6 months)
研究者
研究点 (1)
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