Psychological Impact of Amenorrhea in Women With Endometriosis
NCT ID: NCT02393482
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2021-06-30
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Balanced estroprogestins
Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days.
Estroprogestinic therapy (Etinil-estradiol/levonorgestre)
Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
GnRHa
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.
Gonadotropin-releasing hormone agonist (Leuprorelin acetate)
Leuprorelin acetate (3,75 mg/2 ml)/month
Add back therapy 1 (tibolone)
tibolone 5 mg/die
Add back therapy 2 (calcium carbonate/colecalciferol)
calcium carbonate/colecalciferol (500mg/400UI)/die
Interventions
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Estroprogestinic therapy (Etinil-estradiol/levonorgestre)
Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
Gonadotropin-releasing hormone agonist (Leuprorelin acetate)
Leuprorelin acetate (3,75 mg/2 ml)/month
Add back therapy 1 (tibolone)
tibolone 5 mg/die
Add back therapy 2 (calcium carbonate/colecalciferol)
calcium carbonate/colecalciferol (500mg/400UI)/die
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Psychiatric diseases
* Refusal or inability to sign informed consent
18 Years
40 Years
FEMALE
No
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Stefano Angioni
MD,PhD
Locations
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University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, Italy
Countries
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References
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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.
Other Identifiers
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AMENORREA
Identifier Type: -
Identifier Source: org_study_id
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