A Multi-center, Randomized, Investigator-blinded, Parallel-group Study, Designed to Evaluate the Safety and Clinical Equivalence of Terconazole Vaginal Suppositories, 80 mg (Test Product) and Terconazole Vaginal Suppositories, 80 mg (Reference Product) in the Treatment of Vulvovaginal Candidiasis Caused by Candida Species
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 572
- 主要终点
- Proportion of Subjects in Each Treatment Group With Therapeutic Cure
研究概览
简要总结
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg(Test Product) and Terconazole Vaginal Suppositories, 80 mg(Reference Product) in the treatment of subjects with vulvovaginal candidiasis in order to establish bioequivalence.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 18 years of age
- •Presented with symptomatic vulvovaginitis consistent with a diagnosis of moniliasis
- •Willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol.
排除标准
- •History of hypersensitivity or allergy to imidazoles
- •Female who was pregnant or lactating
- •Was menstruating or expected the onset of menses during the treatment days
- •Had evidence of any bacterial, viral or protozoal infection
- •Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
- •Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
- •Had participated in any investigational study within 30 days prior to study enrollment
研究组 & 干预措施
Test Product
Terconazole Vaginal Suppository
干预措施: Terconazole Vaginal Suppository (Drug)
Reference Product
Terazol Vaginal Suppository
干预措施: Terazol Vaginal Suppository (Drug)
结局指标
主要结局
Proportion of Subjects in Each Treatment Group With Therapeutic Cure
时间窗: Visit 3: Day 22-31
The primary efficacy measure was the proportion of subjects in each treatment group with a therapeutic cure at the Test-of-Cure visit (Visit 3). A subject was considered a therapeutic cure if the subject was a clinical cure with mycological cure.
次要结局
- Proportion of Subjects With Mycological Cure(Visit 3: Day 22-31)
- Proportion of Subjects With Clinical Cure(Visit 3: Day 22-31)