Clinical Trial: Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title:
Brief Summary:
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
Detailed Summary:
Sponsor: University of Cagliari
Current Primary Outcome: Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 45 days of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 90 days of treatment ]
- Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 180 days of treatment ]
- Change of Pelvic pain as measured by visual analogue scale [ Time Frame: Change from baseline pelvic pain at 365 days of treatment ]
- Quality of sexual life [ Time Frame: 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 ]
Original Secondary Outcome: Same as current
Information By: University of Cagliari
Dates:
Date Received: September 20, 2015
Date Started: June 2016
Date Completion: December 2016
Last Updated: March 8, 2016
Last Verified: March 2016