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

Adenomyosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02556411
• Other study ID #: ADENOMYOSIS
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2021
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Chronic Pelvic Pain
• Pelvic Pain

Intervention

Drug:
• LNG-IUS 13,5 mg Levonorgestrel
LNG-IUS
• Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg
Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Cagliari

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pelvic pain as measured by visual analogue scale		Change from baseline pelvic pain at 45 days of treatment
Secondary	Change of Pelvic pain as measured by visual analogue scale		Change from baseline pelvic pain at 90 days of treatment
Secondary	Change of Pelvic pain as measured by visual analogue scale		Change from baseline pelvic pain at 180 days of treatment
Secondary	Change of Pelvic pain as measured by visual analogue scale		Change from baseline pelvic pain at 365 days of treatment
Secondary	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