Overview

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

Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
Female
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
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Cagliari
Treatments:
Contraceptives, Oral
Ethinyl Estradiol
Levonorgestrel
Criteria
Inclusion Criteria:

- Women affected by adenomyosis with pelvic pain > 4;

- Negative Pap Smear test

Exclusion Criteria:

- 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

- Smoke