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临床试验/NCT03456570
NCT03456570Unknown早期 1 期

The Efficacy of Progestins in Treatment of Functional Ovarian Cyst

Assiut University0 个研究点目标入组 90 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
90
主要终点
disappearance of cyst

研究概览

简要总结

The aim of this study is to determine whether the use of progesterone only pills has a beneficial effect over the expectant management of functional ovarian cyst or not , through a sample of female patients within the reproductive years

详细描述

An ovarian cyst is a common gynecological problem and is divided into 2 main categories; physiological and pathological In relative frequency, functional cysts account for about 24% of all ovarian cysts, benign cysts 70% and malignant 6% Functional cysts are the most common masses seen in the premenopausal ovary and are estimated to affect 8%-20% of reproductive-aged women

Pain or discomfort in the lower abdomen Severe pain from torsion (twisting) or rupture - Cyst rupture is characterized by sudden, sharp, unilateral pelvic pain; this can be associated with trauma, exercise, or coitus. Cyst rupture can lead to peritoneal signs, abdominal distention, and bleeding (which is usually self-limited) Discomfort with intercourse, particularly deep penetration Changes in bowel movements such as constipation Pelvic pressure causing tenesmus or urinary frequency Menstrual irregularities Precocious puberty and early menarche in young children Abdominal fullness and bloating Indigestion, heartburn, or early satiety Hyperpyrexia - This may result from some complications of ovarian cysts, such as ovarian torsion Adnexal or cervical motion tenderness In current clinical practice , gynecologists treat functional ovarian cysts with either oral Contraceptive pills or expectant management alone. we presume using progesterone only pills for treatment of functional ovarian cyst

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients at reproductive age (18-44) Menstruating ovarian cyst (a cyst 3-10 cm in diameter, unilateral , unilocular ,clear content) BMI : patients with normal BMI (18.5-24.9) and overweight (25-29.9) included

排除标准

  • Exclusion criteria are ovarian payhology (dermoid, endometriosis or malignancies)
  • Complicated cyst (rupture, torsion) Patients receiving hormonal treatment for the previous 3 cycles History of surgical removal of ovarian cyst Comorbidities like uncontrolled DM ,hypertension and tuberculosis

研究组 & 干预措施

progesterone

Active Comparator

these patients will be offered Dydrogesterone 10 mg twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment

干预措施: Dydrogesterone 10 mg (Drug)

placebo

Placebo Comparator

those patients will be offered placebo tablets twice daily will be offered for 10 days , then they will be seen Post-menstrual or delayed menses for 1 week after treatment

干预措施: Placebo Oral Tablet (Drug)

结局指标

主要结局

disappearance of cyst

时间窗: 2 months

ultrasound evaluation Post-menstrual or delayed menses for 1 week after treatment Patients will be asked about residual symptoms Then TVUS if 1. resolved , another examination will be scheduled after 1 month post-menstrual 2. decreasing in size , another course of treatment will be offered 3. stationary or increasing ,patient will be offered COCs (0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol) 4. complicated ( torsion or rupture ) , patient will be subjected to surgery

次要结局

未报告次要终点

研究者

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

amgad magdy saber

Principal Investigator

Assiut University

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