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临床试验/NCT05474703
NCT05474703Unknown不适用

Evaluating the Effects of Levonorgestrel-releasing Intrauterine Device and Dydrogestreone on Quality of Life and Sexual Life in Patients With Abnormal Uterine Bleeding.

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2022年2月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
171
试验地点
1
主要终点
Short Form- 36 scores (SF-36)

研究概览

简要总结

This study was retrospectively collected from patients who were diagnosed with abnormal uterine bleeding and received oral dydrogesterone therapy for at least six months or who were administered an intrauterine device containing levonorgestrel at least six months ago, and prospectively Short form 36 (P-36); It covers the comparison of the Quality of Life Scale and the Female Sexual Function Scale (FSFI) by asking over the phone.

详细描述

This study aimed to apply to the Gynecology and Obstetrics Clinic of Istanbul Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital between August 2020 and December 2021, diagnosed with abnormal uterine bleeding between the ages of 18-45 and receive oral dydrogesterone treatment for at least six months or an intrauterine device releasing levonorgestrel. A total of 171 sexually active female patients who were treated were included. Of the patients participating in the study, 86 comprised two groups of patients who received LNG-IUD, and 85 received oral dydrogesterone treatment.

This study was retrospectively collected from patients who were diagnosed with abnormal uterine bleeding and received oral dydrogesterone therapy for at least six months or who had an intrauterine device containing levonorgestrel at least six months ago, and prospectively Short form 36 (P-36); It covers the comparison of the Quality of Life Scale and the Female Sexual Function Scale (FSFI) by asking over the phone.

Patients outside the age range of 18-45, sexually inactive patients, patients in pregnancy or postpartum, patients with known malignancy history or suspected malignancy, patients with abnormal smear results, patients with bleeding diathesis, patients using drugs that may cause vaginal bleeding, gynecological patients. Patients with any organic pathology that could explain bleeding on examination, patients with levonorgestrel-releasing intrauterine mediator dislocated, and patients who had previously received different treatments for abnormal uterine bleeding were not included.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Sexually active patients with abnormal uterine bleeding
  • Patients with no known malignancy history or suspected malignancy, patients with average smear results,
  • Patients without bleeding diathesis,
  • Patients using drugs that may cause vaginal bleeding,

排除标准

  • Sexually inactive patients
  • Patients in pregnancy or postpartum period,
  • Patients with a known history of malignancy or suspected malignancy, patients with abnormal smear results,
  • Patients with bleeding diathesis,
  • Patients using drugs that may cause vaginal bleeding, patients with any organic pathology to explain the bleeding in gynecological examination
  • Patients with a dislocated levonorgestrel-releasing intrauterine device
  • Patients who have previously received different treatments for abnormal uterine bleeding

结局指标

主要结局

Short Form- 36 scores (SF-36)

时间窗: 6 months

The difference in quality of life between the two groups will be evaluated with the SF-36 scale.

次要结局

  • The Female Sexual Function Index FSFI scores(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pınar Yalcin bahat

Principial investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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