NCT01256619Unknown2 期
Evaluation of an Oral Contraceptive Containing 30 mg Ethinyloestradiol and 150 mg Desogestrel on Women's Health
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- serum Lipids
研究概览
简要总结
The desogestrel (150 mg) in combination with ethinyl estradiol (EE, 30 mg) is known as Marvelon in European countries. Previous studies revealed that the Marvelon is good and safe for women. As a study from Thailand showed that the Marvelon to be effective and acceptable in Thai women. Moreover compared to Caucasian women, the incidences of irregular bleeding and side effects were apparently lower in these Asian women . Although Marvelon was used in many countries but it's efficacy didn't reported among Iranian women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •being on married, being within 18-40 years old, having normal Body mass index (ranged from 20 to 27 kg/m2), don't use any OCP during 3 months ago, having a normal menstruation cycle for the last three cycles, having at least one of following mental and behavioural symptoms ( Fatigue, mood changes, lack of energy, irritability, aggression, depression, decreased concentration, decreased social relationships, having a greed and increased appetite to eating food), having at least one of following physical symptoms (Breast sensitivity, swelling and flatulence) and women tend to use OCP for six consecutive months.
排除标准
- •pregnancy, having Anorexia or Bulimia, doing breastfeeding, smoke cigarette, Taking sleeping pills more than 3 days per month, Injection estrogen, progesterone or androgen during the past 3 months, Contraindications for OCP (including: thrombophlebitis - Severe liver disease - cerebrovascular accident and heart disease - unexplained uterine bleeding - lupus - breast cancer - migraines - sickle cell anemia - Epilepsy - gallbladder disease - kidney problems - varicocele and family history thrombosis).
研究组 & 干预措施
marvelon
Active Comparator
干预措施: Marvelon (Drug)
结局指标
主要结局
serum Lipids
时间窗: baseline-1 month & 2month & 3month &6month after intervention
次要结局
- PMS(baseline-1 month & 2month & 3month &6month after intervention)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of a Combined Oral Contraceptive of Estradiol Valerate and Dienogest in Healthy Female SubjectsContraceptionNCT01638910Bayer955
已完成
3 期
Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual BleedingMetrorrhagiaNCT01638923Bayer339
终止
不适用
Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?ContraceptionProgestogen Adverse ReactionNCT05174195University Hospital, Geneva67
已完成
不适用
Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid PregnancyContraceptionNCT01602770Bayer1
已完成
1 期
Drug Interaction - Oral ContraceptiveHIV InfectionsNCT00399685Bristol-Myers Squibb28