NCT02556411

Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Comparison of E/P Therapy in Continuous Regimen Versus Combination of LNG-IUS Plus E/P

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Adenomyosis
• Chronic Pelvic Pain

Interventions

Type	Name	Description
DRUG	LNG-IUS 13,5 mg Levonorgestrel	LNG-IUS
DRUG	Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg	Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2015-09-22
• Last updated: 2021-02-04