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NCT02393482 Clinical Trial

Psychological Impact of Amenorrhea in Women With Endometriosis

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02393482
Other study ID # AMENORREA
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 2021
Est. completion date June 2022

Study information
Verified date February 2021
Source University of Cagliari
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Clinical, echographical or surgical diagnosis of endometriosis Exclusion Criteria: - Comorbidity - Psychiatric diseases - Refusal or inability to sign informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
Italy University of Cagliari,Obstetrics and Gynecological Department, Monserrato Cagliari

Sponsors (1)
Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of life (self reported questionnaires) This outcome will be evaluated through self reported questionnaires 180 days
Primary Sexual health (self reported questionnaires) This outcome will be evaluated through self reported questionnaires 180 days
Primary Psychological impact (self reported questionnaires) This outcome will be evaluated through self reported questionnaires 180 days
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