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

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Pelvic Pain, Adenomyosis

Intervention / Treatment
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* Drug: LNG-IUS 13,5 mg Levonorgestrel
* Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LNG-IUS<br>LNG-IUS 13,5 mg di Levonorgestrel | Drug: LNG-IUS 13,5 mg Levonorgestrel<br>* LNG-IUS<br>|
| Experimental: combined oral contraceptive plus LNG-IUS<br>Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg+ LNG-IUS 13,5 mg di Levonorgestrel | Drug: LNG-IUS 13,5 mg Levonorgestrel<br>* LNG-IUS<br>Drug: Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg<br>* Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pelvic pain as measured by visual analogue scale |  | Change from baseline pelvic pain at 45 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pelvic pain as measured by visual analogue scale |  | Change from baseline pelvic pain at 90 days of treatment | 
| Change of Pelvic pain as measured by visual analogue scale |  | Change from baseline pelvic pain at 180 days of treatment | 
| Change of Pelvic pain as measured by visual analogue scale |  | Change from baseline pelvic pain at 365 days of treatment | 
| 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 |