NCT02393482

Psychological Impact of Amenorrhea in Women With Endometriosis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Cagliari · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amenorrhea
• Endometriosis
• Quality of Life

Interventions

Type	Name	Description
DRUG	Estroprogestinic therapy (Etinil-estradiol/levonorgestre)	Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
DRUG	Gonadotropin-releasing hormone agonist (Leuprorelin acetate)	Leuprorelin acetate (3,75 mg/2 ml)/month
DRUG	Add back therapy 1 (tibolone)	tibolone 5 mg/die
DRUG	Add back therapy 2 (calcium carbonate/colecalciferol)	calcium carbonate/colecalciferol (500mg/400UI)/die

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2015-03-19
• Last updated: 2021-02-04

Locations

1 site across 1 country: Italy