Treatment of Menstrual Cycle Alterations in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Menstrual cycle regularity
研究概览
简要总结
the aim of the present study is intended to evaluate how treatment with Myo-Inositol and Dioscorea Villosa can help improve menstrual cycle irregularities in adolescents, both with and without PCOS.
详细描述
The present study aims to evaluate the possible beneficial effect of a treatment with Inofolic HP combined with Inofolic phD on the improvement if menstrual cycle alteration in adolescent patients with or without PCOS.
The molecules chosen for the study are the following: myo-Inositol, α-lactalbumin, Dioscorea Villosa, and Vitamin D, are already commercialized as dietary supplements, commonly administered at same dosage provided in the present study, also for prolonged treatments, with no side effects associated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adolescent women aged 14-19 years old, with at least 3 years passed after menarche, and oligomenorrhea or amenorrhea
排除标准
- •Primary amenorrhea.
- •Hyperandrogenism due to other factors (i.e. adrenal hyperplasia or Cushing syndrome).
- •Hyperprolactinemia or overt hypothyroidism (TSH ≥4).
- •Other hormonal alterations.
- •Ongoing hormonal therapies, including OCPs, six months before enrollment.
- •Ongoing pharmacological therapies.
- •Ongoing use of myo-Inositol supplement or other source of myo-Inositol, or Dioscorea villosa, six months before enrollment.
研究组 & 干预措施
Treated Group HP+phD
干预措施: myo-Inositol plus DIoscorea Villosa (Dietary Supplement)
Controls
Not treated patients
结局指标
主要结局
Menstrual cycle regularity
时间窗: 6 months
The intervention is targed to adolescent patients suffering from menstrual cycle alterations. Particularly, we aim to asses the regularization of the menstrual cycle in those patients with polimenhorrea and oligo-/ amenorrhea, with irregular menstrual cycle (shorter than 21 days or longer than 35 days). The purpose of the study is to compare the percentage of patients exhibiting a regular menstrual cycle at the end of the treatment period, in the study group vs control.
次要结局
未报告次要终点
研究者
Vittorio Unfer
Professor
AGUNCO Obstetrics and Gynecology Centre