NCT01103518Unknown4 期
Phase IV Study of the Use of Two Preparations of Ethinyl Estradiol and Cyproterone Acetate in Irregular Menstruation of Hyper-androgenic Origin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Regular Menstruation
研究概览
简要总结
This is a Phase IV, randomized, double-blind, comparative study of the use of two preparations of ethinyl estradiol and cyproterone acetate in the treatment of menstrual irregularities of hyper-androgenic origin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subject
- •Premenopausal subject
- •18 years or older
- •Medical history of irregular menses lasting at least 3 months
- •Signature of informed consent
排除标准
- •Pregnancy
- •Use of hormonal contraceptives within 3 months of screening
- •Primary bilateral oophorectomy
- •Chemotherapy and / or radiotherapy within 6 months of screening
- •Hysterectomy
- •Myotonic dystrophy
- •Galactosemia
- •Galactorrhea
- •History of tuberculosis or schistosomiasis
- •Elevated prolactin / other significant laboratory alterations
- •Premature ovarian deficiency
- •Sensitivity to any component of the drug formula
研究组 & 干预措施
Combination 1
Experimental
Ethinyl Estradiol + Cyproterone acetate
干预措施: Ethinyl Estradiol + Cyproterone acetate (Drug)
Combination 2
Active Comparator
Ethinyl Estradiol + Cyproterone acetate
干预措施: Ethinyl Estradiol + Cyproterone acetate (Drug)
结局指标
主要结局
Regular Menstruation
时间窗: Treatment month 3
Percentage of subjects with regular menstruation at the end of treatment month 3
次要结局
- Menstrual flow(Treatment months 3)
- Menstrual colic(Treatment month 3)
- Global self evaluation scores(Treatment month 6)
- Willingness to continue treatment(Treatment month 6)
- Safety(Treatment and follow-up period)
- Menstrual Flow(Treatment month 5)
- Menstrual Colic(Treatment month 5)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
EARLY IFNB-1a and Simvastatin Combination Therapy in Clinically Isolated Syndrome Suggestive of Multiple SclerosisMultiple SclerosisNCT00146068University of North Carolina30
已完成
2 期
Basiliximab in Moderate to Severe Ulcerative ColitisUlcerative ColitisNCT00430898Cerimon Pharmaceuticals181
已完成
2 期
Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic SchizophreniaSchizophreniaNCT04461119Newron Pharmaceuticals SPA138
已完成
2 期
A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and ChildrenDengue Hemorrhagic FeverDengue Shock SyndromeDengue FeverNCT00468858U.S. Army Medical Research and Development Command636
已完成
2 期
Study Evaluating ERB-041 With Methotrexate in Rheumatoid ArthritisRheumatoid ArthritisNCT00141830Wyeth is now a wholly owned subsidiary of Pfizer159