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