Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P
概览
- 阶段
- 不适用
- 干预措施
- LNG-IUS 13,5 mg Levonorgestrel
- 疾病 / 适应症
- Adenomyosis
- 发起方
- University of Cagliari
- 入组人数
- 50
- 主要终点
- Change of Pelvic pain as measured by visual analogue scale
- 最后更新
- 5年前
概览
简要总结
Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population.
The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Regarding treatment levonogestrel-releasing intrauterine system, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried. The aim of this study is to compare the efficacy and usefulness of association of oral contraceptive pill and LNG-IUS or LNG-IUS alone
研究者
Stefano Angioni
Associate Professor
University of Cagliari
入排标准
入选标准
- •Women affected by adenomyosis with pelvic pain \> 4;
- •Negative Pap Smear test
排除标准
- •Pregnancy or research of pregnancy
- •Refusal or inability to sign informed consent
- •Severe underlying comorbidities (hepatic, oncological)
- •Pelvic inflammatory disease
- •Other cervical or uterine pathologies
- •Deep venous thromboembolism
- •Hormonal therapy contraindications
研究组 & 干预措施
combined oral contraceptive plus LNG-IUS
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
干预措施: LNG-IUS 13,5 mg Levonorgestrel
LNG-IUS
LNG-IUS 13,5 mg di Levonorgestrel
干预措施: LNG-IUS 13,5 mg Levonorgestrel
combined oral contraceptive plus LNG-IUS
Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
干预措施: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
结局指标
主要结局
Change of Pelvic pain as measured by visual analogue scale
时间窗: Change from baseline pelvic pain at 45 days of treatment
次要结局
- Quality of sexual life(Cases were administered and fulfilled the questionnaires at the moment of diagnosis of adenomyosis up to 4weeks; Change from baseline were evaluated 45 days after begin of treatment)
- Change of Pelvic pain as measured by visual analogue scale(Change from baseline pelvic pain at 365 days of treatment)