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Psychological Impact of Amenorrhea in Women With Endometriosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2016 by University of Cagliari
Sponsor:
Information provided by (Responsible Party):
Stefano Angioni, University of Cagliari
ClinicalTrials.gov Identifier:
NCT02393482
First received: March 9, 2015
Last updated: March 8, 2016
Last verified: March 2016
  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: 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 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 9, 2015
Last Updated: March 8, 2016

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

ClinicalTrials.gov processed this record on March 29, 2017