Genital EndometriosisNCT01294371
Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Lucrin Depot® (Leuprorelin)
An observational study of Genital Endometriosis, run by AbbVie (prior sponsor, Abbott) at 28 sites in Russia.
Trial summary
The purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Genital Endometriosis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 391 participants
- Where
- 28 sitesRussia
- Study dates
- Feb 2011to May 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Primary care clinic
Who may be able to join
- Age from 18 to 50 years
- Written Patient Consent for Use/Disclosure of Data
- Diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis)
- Candidate for treatment with Lucrin Depot for 6-month course
- Patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded
Who cannot join
- Contraindications to administration of Lucrin Depot (leuprorelin):
- Hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition
- Vaginal bleedings of unknown etiology
- Hysterectomy
- Pregnancy and lactation
- Menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program)
Show all 10Show fewer
- Acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs
- Other contraindications that make the patients participation impossible (by investigator judgment)
- Previous enrollment in the present program
- Extra-genital endometriosis
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Russia28 sites
Site Reference ID/Investigator# 51643
Chelyabinsk, 454092
Site Reference ID/Investigator# 50577
Irkutsk, 664003
Site Reference ID/Investigator# 50561
Izhevsk, 426039
Site Reference ID/Investigator# 50560
Kazan', 420043
Site Reference ID/Investigator# 50570
Moscow, 101000
Site Reference ID/Investigator# 50567
Moscow, 117036
Site Reference ID/Investigator# 50565
Moscow, 117997
Site Reference ID/Investigator# 50564
Moscow, 121552
Site Reference ID/Investigator# 62184
Nizhny Novgorod, 603057
Site Reference ID/Investigator# 50558
Nizhny Novgorod, 603126
Site Reference ID/Investigator# 50557
Orenburg, 460000
Site Reference ID/Investigator# 50545
Perm, 614010
Site Reference ID/Investigator# 53156
Perm, 614066
Site Reference ID/Investigator# 50547
Saint Petersburg, 190000
Site Reference ID/Investigator# 50548
Saint Petersburg, 194291
Site Reference ID/Investigator# 50549
Saint Petersburg, 195257
Site Reference ID/Investigator# 50551
Saint Petersburg, 196247
Site Reference ID/Investigator# 50552
Saint Petersburg, 199034
Site Reference ID/Investigator# 50556
Samara, 443067
Site Reference ID/Investigator# 50555
Saratov, 410028
Site Reference ID/Investigator# 50554
Stavropol, 355002
Site Reference ID/Investigator# 50580
Stavropol, 355030
Site Reference ID/Investigator# 50579
Tyumen, 625002
Site Reference ID/Investigator# 50575
Vladivostok, 690600
Site Reference ID/Investigator# 50562
Volzhskiy, Volgograd Region, 404130
Site Reference ID/Investigator# 48866
Voronezh, 394000
Site Reference ID/Investigator# 54502
Voronezh, 394006
Site Reference ID/Investigator# 50563
Yekaterinburg, 620026
About this study
Official title: Prospective, Multi-Center, Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Gonadoliberin Agonist Lucrin Depot.
The purpose of this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.
Read the detailed description
This was a non-interventional, observational program in which Lucrin Depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy).
The rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the Russian Federation. Further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the Russian Federation.
- Conditions
- Genital Endometriosis
- Keywords
- Lucrin Depot, genital endometriosis, 6 months therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Leuprorelin | Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period. Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.
Measured: 6 months
Secondary outcomes (2)
Percent Compliance to Treatment With Leuprorelin
Compliance to treatment was calculated as the number of leuprorelin doses administered / number of doses prescribed * 100.
Measured: 6 months
Participants With Estrogen Deficiency Symptoms
Estrogen deficiency symptoms include:
- hot flashes,
- headaches,
- palpitations at rest,
- insomnia,
- fluctuation of mood.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genital 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almedis
- Responsible party
- Sponsor
- Investigators
- Andrey Strugovshchikov, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294371
- Sponsor's protocol ID
- P12-762
- Status last verified
- May 2013
- First submitted
- 10 Feb 2011
- Last updated
- 22 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Gonadoliberin Agonist Lucrin Depot.
- ClinicalTrials.gov ID
- NCT01294371
- Acronym / sponsor ID
- P12-762
- Conditions
- Genital Endometriosis
- Keywords
- Lucrin Depot, genital endometriosis, 6 months therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Almedis
- Study start
- Feb 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 22 Jul 2013
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 this study is to assess rates of administration of add-back therapy in patients with endometriosis in the Russian Federation, during a 6-month course of gonadoliberin agonist leuprorelin 3.75 mg.
Detailed description
This was a non-interventional, observational program in which Lucrin Depot (leuprorelin acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication (for leuprorelin acetate) and with regards to the local guidelines or therapeutic recommendation (for add-back therapy).
The rationale for the study was the necessity to characterize the patient population and long-term leuprorelin acetate administration in the Russian Federation. Further, it was important to characterize the compliance, tolerability, and safety profile of this therapy in the routine clinical care setting in the Russian Federation.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leuprorelin | – | –Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period. Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- Age from 18 to 50 years
- Written Patient Consent for Use/Disclosure of Data
- Diagnosis of genital endometriosis confirmed by laparoscopy (external genital endometriosis) or ultrasound (internal genital endometriosis)
- Candidate for treatment with Lucrin Depot for 6-month course
- Patients with suspected endometriosis suffering from chronic pelvic pain if other reasons for pain are excluded
Key exclusion criteria (10 listed)
- Contraindications to administration of Lucrin Depot (leuprorelin):
- Menopause (absence of cyclic menstrual hemorrhages for 1 year before the start of this program)
- Acute infectious period, inclusive of acute inflammatory diseases of small pelvic organs
- Other contraindications that make the patients participation impossible (by investigator judgment)
- Previous enrollment in the present program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment
Time frame: 6 months
The percentage of participants who received hormone add-back therapy or non-hormone add-back therapy to reduce estrogen deficiency symptom, following local guidelines or therapeutic recommendations, during the 6-month treatment period with leuprorelin.
2 secondary outcomes
Percent Compliance to Treatment With Leuprorelin
Time frame: 6 months
Participants With Estrogen Deficiency Symptoms
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Andrey Strugovshchikov, MD study director
AbbVie
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genital Endometriosis, run by AbbVie (prior sponsor, Abbott) at 28 sites in Russia.
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 5 inclusion and 10 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 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Russia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Administered Add-back Therapy During a 6-month Course of Leuprorelin Treatment (time frame: 6 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 22 Jul 2013.