Psychological Impact of Amenorrhea in Women With Endometriosis

NCTNCT02393482Other idAMENORREA

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 50 participants (estimated)
Sponsor: University of Cagliari · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Italy
Start: Jun 2021 (estimated)
Primary completion: Dec 2021 (estimated)
Completion: Jun 2022 (estimated)
First posted: 19 Mar 2015 (estimated)
Last update posted: 4 Feb 2021
Conditions: Amenorrhea · Endometriosis · Quality of Life

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023

Ph 4
Psychological Impact of Amenorrhea in Women With Endometriosis
NCT02393482
est. Jun 2021 to est. Jun 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

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)Drug

Arms2

Active comparator
Balanced estroprogestins
Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days.
Active comparator
GnRHa
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 outcomes3

Outcomes the sponsor listed as primary.

Quality of life (self reported questionnaires)
Time frame · 180 days
Registry description
This outcome will be evaluated through self reported questionnaires
Sexual health (self reported questionnaires)
Time frame · 180 days
Registry description
This outcome will be evaluated through self reported questionnaires
Psychological impact (self reported questionnaires)
Time frame · 180 days
Registry description
This outcome will be evaluated through self reported questionnaires

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Clinical, echographical or surgical diagnosis of endometriosis Exclusion Criteria: * Comorbidity * Psychiatric diseases * Refusal or inability to sign informed consent

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