NCT02393482

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
6.2 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

March 9, 2015

Last Update Submit

February 3, 2021

Conditions

AmenorrheaEndometriosisQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Quality of life (self reported questionnaires)

    This outcome will be evaluated through self reported questionnaires

    180 days

  • Sexual health (self reported questionnaires)

    This outcome will be evaluated through self reported questionnaires

    180 days

  • Psychological impact (self reported questionnaires)

    This outcome will be evaluated through self reported questionnaires

    180 days

Study Arms (2)

Balanced estroprogestins

ACTIVE COMPARATOR

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

Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)

GnRHa

ACTIVE COMPARATOR

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.

Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate)Drug: Add back therapy 1 (tibolone)Drug: Add back therapy 2 (calcium carbonate/colecalciferol)

Interventions

Estroprogestinic therapy (Etinil-estradiol/levonorgestre)DRUG

Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die

Balanced estroprogestins
Gonadotropin-releasing hormone agonist (Leuprorelin acetate)DRUG

Leuprorelin acetate (3,75 mg/2 ml)/month

GnRHa
Add back therapy 1 (tibolone)DRUG

tibolone 5 mg/die

GnRHa
Add back therapy 2 (calcium carbonate/colecalciferol)DRUG

calcium carbonate/colecalciferol (500mg/400UI)/die

GnRHa

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical, echographical or surgical diagnosis of endometriosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, 09042, Italy

Location

Related Publications (1)

  • McWilliams LA, Cox BJ, Enns MW. Mood and anxiety disorders associated with chronic pain: an examination in a nationally representative sample. Pain. 2003 Nov;106(1-2):127-33. doi: 10.1016/s0304-3959(03)00301-4.

    PMID: 14581119BACKGROUND

MeSH Terms

Conditions

AmenorrheaEndometriosis

Interventions

Gonadotropin-Releasing HormoneLeuprolidetiboloneCalcium CarbonateCholecalciferol

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 19, 2015

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

IT(1)