AmenorrheaPhase 4NCT02393482
Psychological Impact of Amenorrhea in Women With Endometriosis
A Phase 4 study testing Estroprogestinic therapy (Etinil-estradiol/levonorgestre), Gonadotropin-releasing hormone agonist (Leuprorelin acetate) and Add back therapy 1 (tibolone) in people with Amenorrhea and Endometriosis, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Amenorrhea, Endometriosis, Quality of Life
- What is being tested?
- Estroprogestinic therapy (Etinil-estradiol/levonorgestre), Gonadotropin-releasing hormone agonist (Leuprorelin acetate) and Add back therapy 1 (tibolone)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2021to Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical, echographical or surgical diagnosis of endometriosis
Who cannot join
- Comorbidity
- Psychiatric diseases
- Refusal or inability to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Cagliari,Obstetrics and Gynecological Department,
Monserrato, Cagliari, 09042
About this study
Official title: 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.
- Conditions
- Amenorrhea, Endometriosis, Quality of Life
- Being tested
- Estroprogestinic therapy (Etinil-estradiol/levonorgestre), Gonadotropin-releasing hormone agonist (Leuprorelin acetate), Add back therapy 1 (tibolone), Add back therapy 2 (calcium carbonate/colecalciferol)
- Medical subject headings
- Amenorrhea, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estroprogestinic therapy (Etinil-estradiol/levonorgestre)Drug
Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
Gonadotropin-releasing hormone agonist (Leuprorelin acetate)Drug
Leuprorelin acetate (3,75 mg/2 ml)/month
Add back therapy 1 (tibolone)Drug
tibolone 5 mg/die
Add back therapy 2 (calcium carbonate/colecalciferol)Drug
calcium carbonate/colecalciferol (500mg/400UI)/die
| Study group | Role | What they receive |
|---|---|---|
| Balanced estroprogestins | Active comparator | Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days. Receives: Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre) |
| GnRHa | Active comparator | 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. Receives: Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate); Drug: Add back therapy 1 (tibolone); Drug: Add back therapy 2 (calcium carbonate/colecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (self reported questionnaires)
This outcome will be evaluated through self reported questionnaires
Measured: 180 days
Sexual health (self reported questionnaires)
This outcome will be evaluated through self reported questionnaires
Measured: 180 days
Psychological impact (self reported questionnaires)
This outcome will be evaluated through self reported questionnaires
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Angioni, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393482
- Sponsor's protocol ID
- AMENORREA
- Status last verified
- Feb 2021
- First submitted
- 9 Mar 2015
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 14581119
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Amenorrhea in Women With Endometriosis: Perspective Randomized Study
- ClinicalTrials.gov ID
- NCT02393482
- Acronym / sponsor ID
- AMENORREA
- Conditions
- Amenorrhea, Endometriosis, Quality of Life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced estroprogestins | Active comparator | Drug: Estroprogestinic therapy (Etinil-estradiol/levonorgestre)Women assigned to this arm will assume balanced monophasic estroprogestins (etinil-estradiol 100 mcg/levonorgestrel 20 mcg), one tablet orally daily, for 180 days. |
| GnRHa | Active comparator | Drug: Gonadotropin-releasing hormone agonist (Leuprorelin acetate), Drug: Add back therapy 1 (tibolone), Drug: Add back therapy 2 (calcium carbonate/colecalciferol)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinical, echographical or surgical diagnosis of endometriosis
Key exclusion criteria (3 listed)
- Comorbidity
- Psychiatric diseases
- Refusal or inability to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estroprogestinic therapy (Etinil-estradiol/levonorgestre)Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die | Drug | Balanced estroprogestins |
| Gonadotropin-releasing hormone agonist (Leuprorelin acetate)Leuprorelin acetate (3,75 mg/2 ml)/month | Drug | GnRHa |
| Add back therapy 1 (tibolone)tibolone 5 mg/die | Drug | GnRHa |
| Add back therapy 2 (calcium carbonate/colecalciferol)calcium carbonate/colecalciferol (500mg/400UI)/die | Drug | GnRHa |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 14581119McWilliams 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estroprogestinic therapy (Etinil-estradiol/levonorgestre), Gonadotropin-releasing hormone agonist (Leuprorelin acetate) and Add back therapy 1 (tibolone) in people with Amenorrhea and Endometriosis, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (self reported questionnaires) (time frame: 180 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.