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Psychological Impact of Amenorrhea in Women With Endometriosis

This study is not yet open for participant recruitment.
Verified March 2016 by Stefano Angioni, University of Cagliari
Sponsor:
ClinicalTrials.gov Identifier:
NCT02393482
First Posted: March 19, 2015
Last Update Posted: March 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Stefano Angioni, University of Cagliari:

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

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

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


Estimated Enrollment: 50
Study Start Date: June 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Publications:
Responsible Party: Stefano Angioni, MD,PhD, University of Cagliari
ClinicalTrials.gov Identifier: NCT02393482     History of Changes
Other Study ID Numbers: AMENORREA
First Submitted: March 9, 2015
First Posted: March 19, 2015
Last Update Posted: March 9, 2016
Last Verified: March 2016

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


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