EndometriosisPhase 4NCT00735852
Decapeptyl SR With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women
A Phase 4 study testing Decapeptyl SR 11.25mg in people with Endometriosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a single-centre, open-label, within patient comparison study to assess the efficacy and safety of Decapeptyl SR when administered in combination with Livial for the treatment of women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post treatment follow up. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Decapeptyl SR 11.25mg
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to May 2016
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 and 45 years inclusive
- have a clinical diagnosis of chronic cyclical pelvic pain of at least 6 months duration (with or without evidence of endometriosis)
- have had investigations for possible endometriosis within three years prior to screening visit
- had regular menstrual cycles (24-42 days) for 3 months prior to screening
- treatment with LHRHa is indicated
- must be able to understand and be willing to comply with the requirements of the protocol
Who cannot join
- treated with any LHRHa within 6 months prior to screening
- treated with danazol, gestrinone or cyproterone acetate within 6 months prior to screening
- used cyclical progesterones or combined oral contraceptives within one full menstrual cycle prior to screening
- treated with any other medication other than analgesics within 3 months prior to screening
- continuous or acyclical pelvic pain
- known metabolic bone disease
Show all 17Show fewer
- abnormal full blood count or liver or renal function at screening or within 6 months
- unexplained vaginal bleeding
- bone mineral density age adjusted T Score of -2 or below at screening visit.
- any other medical condition or abnormality that would impact on the safety or efficacy of the study treatment
- receiving treatment with coumarin or indanedione derivatives
- known contraindication or allergy or hypersensitivity to test compounds
- pregnancy or lactation
- planning a pregnancy within 31 months of screening
- of child bearing potential and unwilling to use adequate barrier contraception for the duration of the study
- received any investigational drug therapy within 30 days prior to the study
- has previously entered the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Unit of Reproductive and Developmental Medicine, Jessop Wing, Tree Root Walk
Sheffield, South Yorkshire, S13 8LE
About this study
Official title: A Prospective Single Centre, Single Arm, Open Label Study of the Long Term Use of a LHRA Agonist (Decapeptyl SR, 11.25mg) in Combination With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women
This is a single-centre, open-label, within patient comparison study to assess the efficacy and safety of Decapeptyl SR when administered in combination with Livial for the treatment of women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post treatment follow up. The study aims to recruit 40 patients.
Read the detailed description
A screening visit,will be performed and written informed consent will be obtained from the patient. In addition the patient's medical history will be checked, vital signs recorded, pain and general health questionnaires completed, blood samples collected and any prior or concomitant medications will be noted. Bone density will be determined using a DEXA scan performed in the interval between the screening and baseline visits. One month after the screening visit, patients will return to the clinic for the baseline visit. At this visit a physical examination and urine pregnancy test will be performed, vital signs measured, specific validated questionnaires on pain and endometriosis related health will be completed and symptoms of oestrogen deficiency will be documented. Patients who are still considered to be eligible for the trial will receive an injection of Decapeptyl SR 11.25 mg, and will be dispensed sufficient Livial 2.5 mg tablets to last until the next study visit. Patients will return for repeat Decapeptyl SR injections every 3 months until Month 21 at which time the last Decapeptyl SR injection will be administered. At these visits patients will also be dispensed further supplies of Livial.
Follow-up assessments will be performed during the treatment period 3, 6, 12, 18 and 24 months after the baseline visit. A final follow-up assessment will be conducted 6 months after stopping treatment. At each follow-up visit specific validated questionnaires on pain and endometriosis related health will be collected and symptoms of oestrogen deficiency will be noted. Physical examination, vital signs, bone density assessment and haematology and biochemistry analysis will be repeated at selected timepoints.
Health economic data will be collected at all study visits.
- Conditions
- Endometriosis
- Being tested
- Decapeptyl SR 11.25mg
- Keywords
- endometriosis, chronic cyclical pelvic pain
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decapeptyl SR 11.25mgDrug
Also called Triptorelin acetate
11.25 mgs, Intra muscular (IM) every 3 months for 2 years
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the impact of treatment with Decapeptyl SR plus Livial on CCPP throughout the 24 month treatment period
Measured: baseline, month 12, month 24 and month 30
Secondary outcomes (1)
To asses effect of Decapeptyl SR on pain, disability, overall health status and quality of life
Measured: baseline and 3 monthly until study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startDec 2008
- Primary completionMay 2016
- Study completionMay 2016
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 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Mostafa Metwally, Mr, Principal investigator, Sheffield Teaching Hopsitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735852
- Sponsor's protocol ID
- STH 14404
- Status last verified
- Apr 2019
- First submitted
- 14 Aug 2008
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alshehre SM, Duffy S, Jones G, Ledger WL, Metwally M. A prospective, single-centre, single-arm, open label study of the long term use of a gonadotropin releasing hormone agonist (Triptorelin SR, 11.25 mg) in combination with Tibolone add-back therapy in the management of chronic cyclical pelvic pain. Reprod Biol Endocrinol. 2020 Apr 14;18(1):28. doi: 10.1186/s12958-020-00586-z.
PubMed 32290838
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Centre, Single Arm, Open Label Study of the Long Term Use of a LHRA Agonist (Decapeptyl SR, 11.25mg) in Combination With Livial Add Back Therapy in the Management of Chronic Cyclical Pelvic Pain in Pre Menopausal Women
- ClinicalTrials.gov ID
- NCT00735852
- Acronym / sponsor ID
- STH 14404
- Conditions
- Endometriosis
- Keywords
- endometriosis, chronic cyclical pelvic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Dec 2008
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 15 Aug 2008 (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.
This is a single-centre, open-label, within patient comparison study to assess the efficacy and safety of Decapeptyl SR when administered in combination with Livial for the treatment of women with chronic cyclical pelvic pain. This will be for a 2 year period with a 6 month post treatment follow up. The study aims to recruit 40 patients.
Detailed description
A screening visit,will be performed and written informed consent will be obtained from the patient. In addition the patient's medical history will be checked, vital signs recorded, pain and general health questionnaires completed, blood samples collected and any prior or concomitant medications will be noted. Bone density will be determined using a DEXA scan performed in the interval between the screening and baseline visits. One month after the screening visit, patients will return to the clinic for the baseline visit. At this visit a physical examination and urine pregnancy test will be performed, vital signs measured, specific validated questionnaires on pain and endometriosis related health will be completed and symptoms of oestrogen deficiency will be documented. Patients who are still considered to be eligible for the trial will receive an injection of Decapeptyl SR 11.25 mg, and will be dispensed sufficient Livial 2.5 mg tablets to last until the next study visit. Patients will return for repeat Decapeptyl SR injections every 3 months until Month 21 at which time the last Decapeptyl SR injection will be administered. At these visits patients will also be dispensed further supplies of Livial.
Follow-up assessments will be performed during the treatment period 3, 6, 12, 18 and 24 months after the baseline visit. A final follow-up assessment will be conducted 6 months after stopping treatment. At each follow-up visit specific validated questionnaires on pain and endometriosis related health will be collected and symptoms of oestrogen deficiency will be noted. Physical examination, vital signs, bone density assessment and haematology and biochemistry analysis will be repeated at selected timepoints.
Health economic data will be collected at all study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- aged between 18 and 45 years inclusive
- have a clinical diagnosis of chronic cyclical pelvic pain of at least 6 months duration (with or without evidence of endometriosis)
- have had investigations for possible endometriosis within three years prior to screening visit
- had regular menstrual cycles (24-42 days) for 3 months prior to screening
- treatment with LHRHa is indicated
Key exclusion criteria (17 listed)
- treated with any LHRHa within 6 months prior to screening
- treated with danazol, gestrinone or cyproterone acetate within 6 months prior to screening
- used cyclical progesterones or combined oral contraceptives within one full menstrual cycle prior to screening
- treated with any other medication other than analgesics within 3 months prior to screening
- continuous or acyclical pelvic pain
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 |
|---|---|---|
| Decapeptyl SR 11.25mgAlso: Triptorelin acetate11.25 mgs, Intra muscular (IM) every 3 months for 2 years | Drug | – |
Primary outcome
To assess the impact of treatment with Decapeptyl SR plus Livial on CCPP throughout the 24 month treatment period
Time frame: baseline, month 12, month 24 and month 30
1 secondary outcome
To asses effect of Decapeptyl SR on pain, disability, overall health status and quality of life
Time frame: baseline and 3 monthly until study end
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 18 Apr 2019.
- Derived from this study: PubMed 32290838Alshehre SM, Duffy S, Jones G, Ledger WL, Metwally M. A prospective, single-centre, single-arm, open label study of the long term use of a gonadotropin releasing hormone agonist (Triptorelin SR, 11.25 mg) in combination with Tibolone add-back therapy in the management of chronic cyclical pelvic pain. Reprod Biol Endocrinol. 2020 Apr 14;18(1):28. doi: 10.1186/s12958-020-00586-z.
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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.
Mostafa Metwally, Mr principal investigator
Sheffield Teaching Hopsitals Trust
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 Decapeptyl SR 11.25mg in people with Endometriosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 17 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 18 Apr 2019. 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 United Kingdom. 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?
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?
To assess the impact of treatment with Decapeptyl SR plus Livial on CCPP throughout the 24 month treatment period (time frame: baseline, month 12, month 24 and month 30). 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 NCT00735852, 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 18 Apr 2019.