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Psychological Impact of Amenorrhea in Women With Endometriosis

Primary Purpose

Amenorrhea, Endometriosis, Quality of Life

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Estroprogestinic therapy (Etinil-estradiol/levonorgestre)
Gonadotropin-releasing hormone agonist (Leuprorelin acetate)
Add back therapy 1 (tibolone)
Add back therapy 2 (calcium carbonate/colecalciferol)
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amenorrhea

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical, echographical or surgical diagnosis of endometriosis

Exclusion Criteria:

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

Sites / Locations

  • University of Cagliari,Obstetrics and Gynecological Department,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Balanced estroprogestins

GnRHa

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Quality of life (self reported questionnaires)
This outcome will be evaluated through self reported questionnaires
Sexual health (self reported questionnaires)
This outcome will be evaluated through self reported questionnaires
Psychological impact (self reported questionnaires)
This outcome will be evaluated through self reported questionnaires

Secondary Outcome Measures

Full Information

First Posted
March 9, 2015
Last Updated
February 3, 2021
Sponsor
University of Cagliari
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1. Study Identification

Unique Protocol Identification Number
NCT02393482
Brief Title
Psychological Impact of Amenorrhea in Women With Endometriosis
Official Title
Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amenorrhea, Endometriosis, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balanced estroprogestins
Arm Type
Active Comparator
Arm Description
Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days.
Arm Title
GnRHa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Estroprogestinic therapy (Etinil-estradiol/levonorgestre)
Intervention Description
Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
Intervention Type
Drug
Intervention Name(s)
Gonadotropin-releasing hormone agonist (Leuprorelin acetate)
Intervention Description
Leuprorelin acetate (3,75 mg/2 ml)/month
Intervention Type
Drug
Intervention Name(s)
Add back therapy 1 (tibolone)
Intervention Description
tibolone 5 mg/die
Intervention Type
Drug
Intervention Name(s)
Add back therapy 2 (calcium carbonate/colecalciferol)
Intervention Description
calcium carbonate/colecalciferol (500mg/400UI)/die
Primary Outcome Measure Information:
Title
Quality of life (self reported questionnaires)
Description
This outcome will be evaluated through self reported questionnaires
Time Frame
180 days
Title
Sexual health (self reported questionnaires)
Description
This outcome will be evaluated through self reported questionnaires
Time Frame
180 days
Title
Psychological impact (self reported questionnaires)
Description
This outcome will be evaluated through self reported questionnaires
Time Frame
180 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical, echographical or surgical diagnosis of endometriosis Exclusion Criteria: Comorbidity Psychiatric diseases Refusal or inability to sign informed consent
Facility Information:
Facility Name
University of Cagliari,Obstetrics and Gynecological Department,
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
14581119
Citation
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.
Results Reference
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Psychological Impact of Amenorrhea in Women With Endometriosis

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