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

NCT ID: NCT02556411

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-06-01

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

Conditions

Adenomyosis; Chronic Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LNG-IUS

LNG-IUS 13,5 mg di Levonorgestrel

Group Type: ACTIVE_COMPARATOR

LNG-IUS 13,5 mg Levonorgestrel

Intervention Type: DRUG

LNG-IUS

combined oral contraceptive plus LNG-IUS

Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel

Group Type: EXPERIMENTAL

LNG-IUS 13,5 mg Levonorgestrel

Intervention Type: DRUG

LNG-IUS

Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

Intervention Type: DRUG

Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime

Interventions

LNG-IUS 13,5 mg Levonorgestrel

LNG-IUS

Intervention Type: DRUG

Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Stefano Angioni

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ADENOMYOSIS

Identifier Type: -

Identifier Source: org_study_id