Psychological Impact of Amenorrhea in Women With Endometriosis

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the impact on quality of life, psychological health, sexuality and chronic pain of therapies which determine amenorrhea in symptomatic women with endometriosis, through the administration of self reported questionnaires. Amenorrhea in the first group is caused by balanced assumption of estroprogestins, in the second group is caused by GnRHa-induced hypoestrogenism.

Official Title
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Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study

Conditions
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Amenorrhea, Endometriosis, Quality of Life

Intervention / Treatment
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* Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)
* Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate)
* Drug: Add back therapy 1 (tibolone)
* Drug: Add back therapy 2 (calcium carbonate/colecalciferol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical, echographical or surgical diagnosis of endometriosis Exclusion Criteria: Comorbidity Psychiatric diseases Refusal or inability to sign informed consent

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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No

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: Balanced estroprogestins<br>Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days. | Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)<br>* Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die<br>|
| Active Comparator: GnRHa<br>Women assigned to this arm will assume Leuprorelin acetate (3,75 mg/2ml), one intramuscular administration every 28 days. After 45 days of treatment, therapy will be implemented with Tibolone 5 mg, one tablet daily orally, and Calcium carbonate/colecalciferol (500 mg/400 UI), one tablet daily orally. This therapy will be prosecuted for the remaining 135 days of treatment. | Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate)<br>* Leuprorelin acetate (3,75 mg/2 ml)/month<br>Drug: Add back therapy 1 (tibolone)<br>* tibolone 5 mg/die<br>Drug: Add back therapy 2 (calcium carbonate/colecalciferol)<br>* calcium carbonate/colecalciferol (500mg/400UI)/die<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (self reported questionnaires) | This outcome will be evaluated through self reported questionnaires | 180 days | 
| Sexual health (self reported questionnaires) | This outcome will be evaluated through self reported questionnaires | 180 days | 
| Psychological impact (self reported questionnaires) | This outcome will be evaluated through self reported questionnaires | 180 days |