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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balanced estroprogestins | Active Comparator | Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days. |
|
| GnRHa | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estroprogestinic therapy (Etinil-estradiol/levonorgestre) | Drug | Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cagliari,Obstetrics and Gynecological Department, | Monserrato | Cagliari | 09042 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14581119 | Background | McWilliams LA, Cox BJ, Enns MW. Mood and anxiety disorders associated with chronic pain: an examination in a nationally representative sample. Pain. 2003 Nov;106(1-2):127-33. doi: 10.1016/s0304-3959(03)00301-4. |
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| Gonadotropin-releasing hormone agonist (Leuprorelin acetate) | Drug | Leuprorelin acetate (3,75 mg/2 ml)/month |
|
| Add back therapy 1 (tibolone) | Drug | tibolone 5 mg/die |
|
| Add back therapy 2 (calcium carbonate/colecalciferol) | Drug | calcium carbonate/colecalciferol (500mg/400UI)/die |
|
| ID | Term |
|---|---|
| D000568 | Amenorrhea |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| C027385 | tibolone |
| D002119 | Calcium Carbonate |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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