EndometriosisPhase 3NCT01712763
Degarelix in the Treatment of Endometriosis Recurrence
A Phase 3 study testing degarelix and Leuprolide Acetate 11.25 MG/ML (Enantone 11,25) in people with Endometriosis, run by Centre for Endocrinology and Reproductive Medicine, Italy at 3 sites in 3 countries.
Trial summary
The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- degarelix and Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2012to Mar 2016
- Phase
- Phase 3
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women affected by endometriosis showing recurrence of pain symptoms
- previous surgery for endometriosis
Who cannot join
- presence of other systemic diseases
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
The long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.
Read the detailed description
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.
- Conditions
- Endometriosis
- Being tested
- degarelix, Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)
- Keywords
- Endometriosis, long acting GnRH antagonist, Degarelix, Recurrence, Pelvic Pain
- Medical subject headings
- Endometriosis, Recurrence, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
degarelixDrug
Also called firmagon
180 women will be treated with degarlix 120 mg, in only one administration covering three months
Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)Drug
Also called Enantone 11.25
180 women will be treated with leuprolide acetate11.25 only once covering three months
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | 180 women will be treated with degarelix 120mg in one administration Receives: Drug: degarelix |
| leuprolide acetate 11.25 mg/ml | Active comparator | 180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months Receives: Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25) |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free time
time without pain symptoms due to the disease recurrence
Measured: 24 months
Secondary outcomes (1)
time of disappearance pain
time needed during treatment to improve the pain symptoms
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- MARCO SBRACIA, MD, Study chair, Centre for Endocrinology and Reproductive Medicine, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712763
- Sponsor's protocol ID
- C06/2012
- Status last verified
- Feb 2022
- First submitted
- 18 Oct 2012
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Long Acting GnRH Antagonist Degarelix in Women With Endometriosis Recurrence
- ClinicalTrials.gov ID
- NCT01712763
- Acronym / sponsor ID
- C06/2012
- Conditions
- Endometriosis
- Keywords
- Endometriosis, long acting GnRH antagonist, Degarelix, Recurrence, Pelvic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Centre for Endocrinology and Reproductive Medicine, ItalyResearch network
- Study start
- Nov 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Oct 2012 (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 long acting GnRH antagonist degarelix will be tested for the treatment of women with endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom disappearance and disease free time during follow-up will be the outcomes for establishing which medical treatment is the best in endometriosis recurrence treatment.
Detailed description
Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist and strongly suppress LH secretion and thecal cell activity may show a better effects on endometrial implants than GnRH agonist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix | Experimental | Drug: degarelix180 women will be treated with degarelix 120mg in one administration |
| leuprolide acetate 11.25 mg/ml | Active comparator | Drug: Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)180 women will be treated with leuprolide acetate 11.25 mg/ml only once covering three months |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women affected by endometriosis showing recurrence of pain symptoms
- previous surgery for endometriosis
Key exclusion criteria (1 listed)
- presence of other systemic diseases
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 |
|---|---|---|
| degarelixAlso: firmagon180 women will be treated with degarlix 120 mg, in only one administration covering three months | Drug | Degarelix |
| Leuprolide Acetate 11.25 MG/ML (Enantone 11,25)Also: Enantone 11.25180 women will be treated with leuprolide acetate11.25 only once covering three months | Drug | leuprolide acetate 11.25 mg/ml |
Primary outcome
disease free time
Time frame: 24 months
time without pain symptoms due to the disease recurrence
1 secondary outcome
time of disappearance pain
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
MARCO SBRACIA, MD study chair
Centre for Endocrinology and Reproductive Medicine, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing degarelix and Leuprolide Acetate 11.25 MG/ML (Enantone 11,25) in people with Endometriosis, run by Centre for Endocrinology and Reproductive Medicine, Italy at 3 sites in 3 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Albania, Bulgaria, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
disease free time (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.