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Psychological Impact of Amenorrhea in Women With Endometriosis

NCT02393482 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02393482 on ClinicalTrials.gov