- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393482
Psychological Impact of Amenorrhea in Women With Endometriosis
February 3, 2021 updated by: Stefano Angioni, University of Cagliari
Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cagliari
-
Monserrato, Cagliari, Italy, 09042
- University of Cagliari,Obstetrics and Gynecological Department,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Clinical, echographical or surgical diagnosis of endometriosis
Exclusion Criteria:
- Comorbidity
- Psychiatric diseases
- Refusal or inability to sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Leuprorelin acetate (3,75 mg/2 ml)/month
tibolone 5 mg/die
calcium carbonate/colecalciferol (500mg/400UI)/die
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life (self reported questionnaires)
Time Frame: 180 days
|
This outcome will be evaluated through self reported questionnaires
|
180 days
|
Sexual health (self reported questionnaires)
Time Frame: 180 days
|
This outcome will be evaluated through self reported questionnaires
|
180 days
|
Psychological impact (self reported questionnaires)
Time Frame: 180 days
|
This outcome will be evaluated through self reported questionnaires
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2021
Primary Completion (Anticipated)
December 1, 2021
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
March 9, 2015
First Submitted That Met QC Criteria
March 18, 2015
First Posted (Estimate)
March 19, 2015
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 3, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Menstruation Disturbances
- Endometriosis
- Amenorrhea
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Antineoplastic Agents
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens
- Micronutrients
- Hormone Antagonists
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Estrogen Receptor Modulators
- Androgen Antagonists
- Antacids
- Anabolic Agents
- Vitamin D
- Cholecalciferol
- Leuprolide
- Estradiol
- Hormones
- Calcium Carbonate
- Tibolone
Other Study ID Numbers
- AMENORREA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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