Psychological Impact of Amenorrhea in Women With Endometriosis

Phase 4

• Conditions: Amenorrhea; Endometriosis; Quality of Life
• Interventions: Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre); Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate); Drug: Add back therapy 1 (tibolone); Drug: Add back therapy 2 (calcium carbonate/colecalciferol)

• Registration Number: NCT02393482
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04
• Study Start: 2021-06
• Primary Completion: 2021-12
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Clinical, echographical or surgical diagnosis of endometriosis

Exclusion Criteria

• Comorbidity
• Psychiatric diseases
• Refusal or inability to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balanced estroprogestins	Estroprogestinic therapy (Etinil-estradiol/levonorgestre)	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	Gonadotropin-releasing hormone agonist (Leuprorelin acetate)	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.
GnRHa	Add back therapy 1 (tibolone)	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.
GnRHa	Add back therapy 2 (calcium carbonate/colecalciferol)	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.

Primary Outcome Measures

Name	Time	Method
Sexual health (self reported questionnaires)	180 days	This outcome will be evaluated through self reported questionnaires
Quality of life (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

Trial Locations

Locations (1)

University of Cagliari,Obstetrics and Gynecological Department,; 🇮🇹 Monserrato, Cagliari, Italy