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临床试验/NCT03124524
NCT03124524已完成4 期

Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea?

Adana Numune Training and Research Hospital0 个研究点目标入组 99 人开始时间: 2015年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
99
主要终点
Doppler indices of uterine artery blood flows.

研究概览

简要总结

Our aim is to evaluate and compare the pain relief of estradiol valerate/dienogest and ethinylestradiol/ drospirenone by using doppler indices.

100 nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting contraception aged from 18 to 35 were included to the study. Visual analog scale (VAS), the uterine artery doppler indices including systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels before treatment. The 66 PD patients who met the inclusion criteria were divided into 2 groups and 33 healthy controls created Group 1. Group 2 were administered estradiol valerate/dienogest while Group 3 were administered 0.03 mg ethinylestradiol and 3 mg drospirenone. Both VAS scores and doppler indices were repeated after 3 months treatment. The changes in values were recorded.

详细描述

This prospective, randomized, controlled clinical trial was conducted in Kayseri Education and Research Hospital, in Turkey between 2015 and 2016. Nullipara patients with symptoms of severe primary dysmenorrhea (PD) requesting contraception aged from 18 to 35 were included to the study. Afterwards, based on computer generated random numbers the patients were allocated to one of the two study arms; Group2 (Qlarista group) and Group3 (yasmin group), equally.

The PD was diagnosed clinically. The characteristic of pain was periodic (at least following 3 menstrual cycles), midline, lower abdominal cramps or pelvic colic like pain that starts up to one day before menses, lasts for the 3 days of bleeding, gradually diminishes over 12 to 72 hours and ends after period. The pain starts generally in 2 to 3 years after menarche with regular menses (25-31 day). Also absence of pelvic pathology was important in these patients for diagnosis.

Patients with history of pelvic inflammatory diseases, endometriosis, ovarian cysts, chronic abdominal pain, fibroids, obstructive endometrial polyps, cervical stenosis, inflammatory bowel syndrome, irritable bowel syndrome, major abdominal or pelvic surgery, intrauterine device and congenital obstructive müllerian malformations were excluded. Smoking, overweighted (body mass index (BMI) ≥ 30) patients that oral contraceptive pills (OCP) treatment was contraindicated were also excluded. Additionally, patients enrolled simultaneously into other studies that require drug intake or otherwise prevent compliance with protocol were out of the study.

Visual analog scale (VAS) from 0 (no pain) to 10 (maximum pain, 'worst pain I have ever felt') was applied to patients on the first day of menstrual cycle. Patients with VAS score of between 7 to10 and PD accompanied with vomiting, nausea, dizziness, headache, nervousness, diarrhea and fatigue were classified as severe PD. The ages (years), BMI (kg/m2), length of menstrual cycle (days) and length of bleeding (days) and demographic data of patients were recorded.

Before treatment during menstruation period all ultrasound examinations were carried out trans abdominally with Toshiba Xario machine ( Shimoishigami, Otawara-shi, Tochigi 324-8550, Japan) equipped with a 2.8-7 megahertz (MHz) transducer by a single radiologist (Ş.T.) The uterine artery blood flows were measured at the lateral level of uterine artery neighbour to cervicocorporeal junction in both sides (right and left). Doppler indices including systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels. Both VAS scores and doppler indices were repeated after 3 months treatment. The changes in values were recorded.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • must be nullipara patients with symptoms of severe primary dysmenorrhea.
  • The characteristic of pain must be periodic (at least following 3 menstrual cycles),
  • lower abdominal cramps or pelvic colic like pain that starts up to one day before menses,
  • lasts for the 3 days of bleeding,
  • gradually diminishes over 12 to 72 hours,
  • ends after period.
  • The pain must start generally in 2 to 3 years after menarche with regular menses (25-31 day).

排除标准

  • Patients with history of pelvic inflammatory diseases,
  • endometriosis,
  • ovarian cysts,
  • chronic abdominal pain,
  • fibroids,
  • obstructive endometrial polyps,
  • cervical stenosis,
  • inflammatory bowel syndrome,
  • irritable bowel syndrome,
  • major abdominal or pelvic surgery,
  • intrauterine device,
  • congenital obstructive müllerian malformations.
  • patients that OCP treatment was contraindicated
  • patients enrolled simultaneously into other studies that require drug intake or otherwise prevent compliance with protocol.

研究组 & 干预措施

Qlarista Group

Active Comparator

group who were administered estradiol valerate/dienogest

干预措施: estradiol valerate/dienogest (Drug)

Yasmin Group

Active Comparator

group who were administered ethinylestradiol and drospirenone

干预措施: ethinylestradiol and drospirenone (Drug)

结局指标

主要结局

Doppler indices of uterine artery blood flows.

时间窗: up to 10 minutes

Before and treatment during menstruation period the uterine artery blood flows were measured at the lateral level of uterine artery neighbour to cervicocorporeal junction in both sides (right and left). Doppler indices including systole/diastole rates ( S/D), pulsatility index (PI) and resistance index (RI) values were evaluated and recorded in both uterine vessels.

次要结局

  • Questionnaire Questionarie: Pain relief by using Visual analog scale (VAS) before and after treatment.(up to 10 minutes)

研究者

发起方
Adana Numune Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gulsum Uysal

Principal Investigator, MD.

Adana Numune Training and Research Hospital

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