Amenorrhea, Endometriosis, Quality of Life
Conditions
Brief 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.
Interventions
DRUGEstroprogestinic therapy (Etinil-estradiol/levonorgestre)
Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
DRUGGonadotropin-releasing hormone agonist (Leuprorelin acetate)
Leuprorelin acetate (3,75 mg/2 ml)/month
DRUGAdd back therapy 1 (tibolone)
tibolone 5 mg/die
DRUGAdd back therapy 2 (calcium carbonate/colecalciferol)
calcium carbonate/colecalciferol (500mg/400UI)/die
Sponsors
University of Cagliari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Clinical, echographical or surgical diagnosis of endometriosis
Exclusion criteria
* Comorbidity * Psychiatric diseases * Refusal or inability to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (self reported questionnaires) | 180 days | This outcome will be evaluated through self reported questionnaires |
| Sexual health (self reported questionnaires) | 180 days | This outcome will be evaluated through self reported questionnaires |
| Psychological impact (self reported questionnaires) | 180 days | This outcome will be evaluated through self reported questionnaires |
Countries
Italy
Outcome results
None listed