NCT00160199已完成4 期
Evaluation of Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion of Endometrium and Withdrawal Bleeding in Subjects With Secondary Amenorrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 42
- 主要终点
- Secretory Conversion of the Endometrium
研究概览
简要总结
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with secondary amenorrhea
- •Normal serum Dehydroepiandrosterone (DHEA), prolactin, testosterone, Thyroid Stimulating Hormone (TSH) and thyroxine
排除标准
- •Primary amenorrhea
- •Other medical conditions resulting in amenorrhea (e.g. Asherman's syndrome)
- •Peanut allergy
- •Allergy to progestational steroids
研究组 & 干预措施
1
Experimental
干预措施: PROMETRIUM® 300 mg (Drug)
2
Active Comparator
干预措施: PROMETRIUM® 400 mg (Drug)
结局指标
主要结局
Secretory Conversion of the Endometrium
时间窗: End of the study (Days 85)
Endometrial biopsy results were classified as : Secretory (Complete or partial), Non-secretory, Unable to determine or Unknown after an evaluation of morphologic criteria.
Number of Subjects With Withdrawal Bleeding
时间窗: After first and second cycle (cycle=28 days)
This measure is the number of subjects with withdrawal bleeding using Last Observation Carried Forward (LOCF) after first and second cycle.
次要结局
- Maximum Intensity of Withdrawal Bleeding After Any Cycle(Duration of withdrawal bleed)
- The Duration of Withdrawal Bleeding After the First Treatment Cycle(End of the first cycle of treatment (cycle=28 days))
- The Duration of Withdrawal Bleeding After Second Treatment Cycle(End of the second cycle of treatment (cycle=28 days))
- Time to Withdrawal Bleeding After First Treatment Cycle(End of the first cycle of treatment (cycle=28 days))
- Time to Withdrawal Bleeding After Second Treatment Cycle(End of the second cycle of treatment (cycle=28 days))
研究者
研究点 (42)
Loading locations...
相似试验
已完成
3 期
Study of Pemetrexed + Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With Tyrosine Kinase Inhibitor- (TKI)-Resistant Epidermal Growth Factor Receptor- (EGFR)-Mutated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-789/KEYNOTE-789)Non-small Cell Lung CancerNCT03515837Merck Sharp & Dohme LLC492
已完成
不适用
Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.Luteal Phase DefectNCT04722471Instituto Bernabeu347
已完成
1 期
Profermin® in Active Ulcerative ColitisUlcerative ColitisNCT01245465Nordisk Rebalance A/S39
进行中（未招募）
不适用
Study of the Safety and Effectiveness of Motiva Implants®Breast ImplantsNCT03579901Motiva USA LLC800
已完成
不适用
IRIS-PREMIER REGISTRYCoronary Artery DiseaseCoronary DiseaseHeart DiseasesMyocardial IschemiaNCT02060968Seung-Jung Park2,006