Specific Supplementation in Counteracting the Adverse Effects of Oral Contraceptives
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- cellulite
研究概览
简要总结
Prospective, controlled study. Administration of a specifically formulated supplement to women prescribed oral contraceptives. Evaluation of: a) reduction of adverse effects of the treatment; b) improvement of patients' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index: 18-30 Kg/m2;
- •Prescription for COC treatment
排除标准
- •previous or existing breast pathologies;
- •hypertension;
- •smoking habits;
- •cardiovascular disorders
研究组 & 干预措施
Control group
Patients prescribed estroprogestinic oral contraceptive
干预措施: Oral contraceptive (Drug)
Study group
Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement
干预措施: Zyxelle (Dietary Supplement)
Study group
Patients prescribed estroprogestinic oral contraceptive were treatedwith Zyxelle supplement
干预措施: Oral contraceptive (Drug)
结局指标
主要结局
cellulite
时间窗: Change from baseline cellulite status at 3 months
patients' self-assessed evaluation through a questionnaire
water retention
时间窗: Change from baseline extracellular body water content at 3 months
Bioelectrical impedance analysis (BIA)
次要结局
- mood(Change from baseline mood at 3 months)