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

Not Applicable

• Conditions: Chronic Pelvic Pain; Adenomyosis
• Interventions: Drug: LNG-IUS 13,5 mg Levonorgestrel; Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg

• Registration Number: NCT02556411
• Lead Sponsor: University of Cagliari

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-22
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04
• Study Start: 2021-06-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined oral contraceptive plus LNG-IUS	LNG-IUS 13,5 mg Levonorgestrel	Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
combined oral contraceptive plus LNG-IUS	Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg	Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel
LNG-IUS	LNG-IUS 13,5 mg Levonorgestrel	LNG-IUS 13,5 mg di Levonorgestrel

Primary Outcome Measures

Name	Time	Method
Change of Pelvic pain as measured by visual analogue scale	Change from baseline pelvic pain at 45 days of treatment

Secondary Outcome Measures

Name	Time	Method
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
Change of Pelvic pain as measured by visual analogue scale	Change from baseline pelvic pain at 365 days of treatment