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Psychological Impact of Amenorrhea in Women With Endometriosis

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ClinicalTrials.gov Identifier: NCT02393482
Recruitment Status : Not yet recruiting
First Posted : March 19, 2015
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Stefano Angioni, 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.

Condition or disease Intervention/treatment Phase
Amenorrhea Endometriosis Quality of Life 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) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
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.
Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)
Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die

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.
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




Primary Outcome Measures :
  1. Quality of life (self reported questionnaires) [ Time Frame: 180 days ]
    This outcome will be evaluated through self reported questionnaires

  2. Sexual health (self reported questionnaires) [ Time Frame: 180 days ]
    This outcome will be evaluated through self reported questionnaires

  3. Psychological impact (self reported questionnaires) [ Time Frame: 180 days ]
    This outcome will be evaluated through self reported questionnaires



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical, echographical or surgical diagnosis of endometriosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393482


Locations
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Italy
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, Italy, 09042
Sponsors and Collaborators
University of Cagliari

Publications:
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Responsible Party: Stefano Angioni, MD,PhD, University of Cagliari
ClinicalTrials.gov Identifier: NCT02393482     History of Changes
Other Study ID Numbers: AMENORREA
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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

Additional relevant MeSH terms:
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Endometriosis
Amenorrhea
Genital Diseases, Female
Menstruation Disturbances
Pathologic Processes
Hormones
Estradiol
Polyestradiol phosphate
Tibolone
Calcium
Cholecalciferol
Calcium, Dietary
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Leuprolide
Calcium Carbonate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Fertility Agents, Female
Fertility Agents
Antineoplastic Agents, Hormonal