Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS) (LEMON)

January 12, 2012 updated by: Abbott

Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.

The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The remaining target is:

- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
729

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

  • Poland
      • Belchatow, Poland, 97-400
        • Site Reference ID/Investigator# 31076
      • Bialystok, Poland, 11-300
        • Site Reference ID/Investigator# 31002
      • Bialystok, Poland, 15-027
        • Site Reference ID/Investigator# 30977
      • Bialystok, Poland, 15-161
        • Site Reference ID/Investigator# 31030
      • Bialystok, Poland, 15-201
        • Site Reference ID/Investigator# 31048
      • Bobrowniki, Poland, 42-583
        • Site Reference ID/Investigator# 31083
      • Brwinow, Poland, 05-840
        • Site Reference ID/Investigator# 30976
      • Bydgoszcz, Poland, 85-209
        • Site Reference ID/Investigator# 31028
      • Bytom, Poland, 41-902
        • Site Reference ID/Investigator# 31014
      • Bytom, Poland, 41-908
        • Site Reference ID/Investigator# 31006
      • Bytom, Poland, 41-933
        • Site Reference ID/Investigator# 31018
      • Ciechanow, Poland, 06-400
        • Site Reference ID/Investigator# 31007
      • Elblag, Poland, 82-300
        • Site Reference ID/Investigator# 31004
      • Elblag, Poland, 82-300
        • Site Reference ID/Investigator# 31090
      • Elk, Poland, 19-300
        • Site Reference ID/Investigator# 31044
      • Florentynow, Poland, 95-083
        • Site Reference ID/Investigator# 30994
      • Gdansk, Poland, 80-305
        • Site Reference ID/Investigator# 9803
      • Gdansk, Poland, 80-371
        • Site Reference ID/Investigator# 31057
      • Gdansk, Poland, 80-462
        • Site Reference ID/Investigator# 31101
      • Gdansk, Poland, 80-858
        • Site Reference ID/Investigator# 31097
      • Gliwice, Poland, 44-100
        • Site Reference ID/Investigator# 30984
      • Imielnik Stary, Poland, 95-010
        • Site Reference ID/Investigator# 31051
      • Inowroclaw, Poland, 88-100
        • Site Reference ID/Investigator# 31023
      • Inowroclaw, Poland, 88-100
        • Site Reference ID/Investigator# 31074
      • Jankowo, Poland, 80-180
        • Site Reference ID/Investigator# 31032
      • Jaroslawiec, Poland, 37-500
        • Site Reference ID/Investigator# 31067
      • Jastkow, Poland, 21-002
        • Site Reference ID/Investigator# 30995
      • Jastrzebie Zdroj, Poland, 44-330
        • Site Reference ID/Investigator# 31065
      • Jastrzebie Zdroj, Poland, 44-335
        • Site Reference ID/Investigator# 31031
      • Jelenia Gora, Poland, 58-500
        • Site Reference ID/Investigator# 31054
      • Katowice, Poland, 40-060
        • Site Reference ID/Investigator# 30997
      • Katowice, Poland, 40-683
        • Site Reference ID/Investigator# 31036
      • Kielce, Poland, 25-132
        • Site Reference ID/Investigator# 31055
      • Kielce, Poland, 25-372
        • Site Reference ID/Investigator# 30999
      • Kluczbork, Poland, 46-200
        • Site Reference ID/Investigator# 31102
      • Kolbudy, Poland, 83-83-050
        • Site Reference ID/Investigator# 31068
      • Konin, Poland, 62-510
        • Site Reference ID/Investigator# 31020
      • Krakow, Poland, 30-054
        • Site Reference ID/Investigator# 31019
      • Krakow, Poland, 30-082
        • Site Reference ID/Investigator# 31087
      • Krakow, Poland, 30-111
        • Site Reference ID/Investigator# 31050
      • Krakow, Poland, 31-153
        • Site Reference ID/Investigator# 31025
      • Krakow, Poland, 31-348
        • Site Reference ID/Investigator# 31043
      • Krakow, Poland, 31-467
        • Site Reference ID/Investigator# 31011
      • Krakow, Poland, 31-559
        • Site Reference ID/Investigator# 31061
      • Krakow, Poland
        • Site Reference ID/Investigator# 31053
      • Kurow, Poland, 24-170
        • Site Reference ID/Investigator# 31029
      • Lask, Poland, 98-100
        • Site Reference ID/Investigator# 31010
      • Lazy, Poland, 42-450
        • Site Reference ID/Investigator# 31096
      • Legnica, Poland, 59-220
        • Site Reference ID/Investigator# 31012
      • Leszno, Poland, 64-100
        • Site Reference ID/Investigator# 31040
      • Lidzbark Warminski, Poland, 11-100
        • Site Reference ID/Investigator# 31082
      • Lodz, Poland, 91-425
        • Site Reference ID/Investigator# 31086
      • Lodz, Poland, 91-502
        • Site Reference ID/Investigator# 31052
      • Lodz, Poland, 91-719
        • Site Reference ID/Investigator# 31047
      • Lodz, Poland, 93-513
        • Site Reference ID/Investigator# 31089
      • Lodz, Poland, 93-588
        • Site Reference ID/Investigator# 31060
      • Lomza, Poland, 18-400
        • Site Reference ID/Investigator# 31039
      • Lublin, Poland, 20-352
        • Site Reference ID/Investigator# 31049
      • Lublin, Poland, 20-468
        • Site Reference ID/Investigator# 31100
      • Lublin, Poland, 20-554
        • Site Reference ID/Investigator# 33278
      • Lublin, Poland, 20-718
        • Site Reference ID/Investigator# 31103
      • Lublin, Poland, 20-718
        • Site Reference ID/Investigator# 31104
      • Lublin, Poland, 20-827
        • Site Reference ID/Investigator# 30998
      • Michalowice Osiedle, Poland, 05-816
        • Site Reference ID/Investigator# 31056
      • Milcz, Poland, 56-300
        • Site Reference ID/Investigator# 31001
      • Nysa, Poland, 48-300
        • Site Reference ID/Investigator# 31085
      • Oborniki Slaskie, Poland, 55-120
        • Site Reference ID/Investigator# 30993
      • Olsztyn, Poland, 10-229
        • Site Reference ID/Investigator# 30974
      • Olsztyn, Poland, 10-950
        • Site Reference ID/Investigator# 31080
      • Opole, Poland, 45-002
        • Site Reference ID/Investigator# 30989
      • Opole, Poland, 45-007
        • Site Reference ID/Investigator# 30978
      • Opole, Poland, 45-061
        • Site Reference ID/Investigator# 30982
      • Opole, Poland, 45-367
        • Site Reference ID/Investigator# 31033
      • Opole, Poland, 45-367
        • Site Reference ID/Investigator# 31075
      • Ostrow Wielkopolski, Poland, 63-400
        • Site Reference ID/Investigator# 31042
      • Pila, Poland, 64-920
        • Site Reference ID/Investigator# 31069
      • Piotrkow Trybunalski, Poland, 97-300
        • Site Reference ID/Investigator# 31000
      • Plock, Poland, 09-409
        • Site Reference ID/Investigator# 31013
      • Poddebice, Poland, 99-200
        • Site Reference ID/Investigator# 31009
      • Poznan, Poland, 60-195
        • Site Reference ID/Investigator# 31045
      • Poznan, Poland, 60-232
        • Site Reference ID/Investigator# 31088
      • Poznan, Poland, 60-362
        • Site Reference ID/Investigator# 31021
      • Poznan, Poland, 60-409
        • Site Reference ID/Investigator# 31058
      • Poznan, Poland, 60-638
        • Site Reference ID/Investigator# 31034
      • Poznan, Poland, 60-835
        • Site Reference ID/Investigator# 30985
      • Pulawy, Poland, 24-100
        • Site Reference ID/Investigator# 31005
      • Pulawy, Poland, 24-100
        • Site Reference ID/Investigator# 31064
      • Puszczykowo, Poland, 62-041
        • Site Reference ID/Investigator# 30979
      • Pyskowice, Poland, 44-120
        • Site Reference ID/Investigator# 31022
      • Radlin, Poland, 44-310
        • Site Reference ID/Investigator# 31016
      • Radom, Poland, 26-610
        • Site Reference ID/Investigator# 31099
      • Rzeszow, Poland, 35-003
        • Site Reference ID/Investigator# 31041
      • Siedlce, Poland, 08-110
        • Site Reference ID/Investigator# 31024
      • Siemianowice Slaskie, Poland, 41-106
        • Site Reference ID/Investigator# 30988
      • Sieradz, Poland, 98-200
        • Site Reference ID/Investigator# 31063
      • Sosnowiec, Poland, 41-200
        • Site Reference ID/Investigator# 31015
      • Starachowice, Poland, 27-300
        • Site Reference ID/Investigator# 30983
      • Suwalki, Poland, 16-400
        • Site Reference ID/Investigator# 31084
      • Suwalki, Poland, 16-400
        • Site Reference ID/Investigator# 31092
      • Suwałki, Poland, 16-400
        • Site Reference ID/Investigator# 33277
      • Swarzedz, Poland, 62-020
        • Site Reference ID/Investigator# 31008
      • Swietochlowice, Poland, 41-608
        • Site Reference ID/Investigator# 31003
      • Szczecin, Poland, 70-123
        • Site Reference ID/Investigator# 30975
      • Szczecin, Poland, 71-050
        • Site Reference ID/Investigator# 31046
      • Szczecin, Poland, 71-126
        • Site Reference ID/Investigator# 30992
      • Szczecin, Poland, 71-132
        • Site Reference ID/Investigator# 31035
      • Tarnow, Poland, 33-100
        • Site Reference ID/Investigator# 31071
      • Tarnow, Poland, 33-100
        • Site Reference ID/Investigator# 31091
      • Tarnowskie Gory, Poland, 42-600
        • Site Reference ID/Investigator# 31079
      • Tomaszow Mazowiecki, Poland, 97-200
        • Site Reference ID/Investigator# 30980
      • Torun, Poland, 87-100
        • Site Reference ID/Investigator# 31059
      • Turek, Poland, 62-700
        • Site Reference ID/Investigator# 30987
      • Warsaw, Poland, 01-636
        • Site Reference ID/Investigator# 31066
      • Warsaw, Poland, 02-156
        • Site Reference ID/Investigator# 31037
      • Warsaw, Poland, 02-507
        • Site Reference ID/Investigator# 31105
      • Warsaw, Poland, 02-507
        • Site Reference ID/Investigator# 31106
      • Warsaw, Poland, 02-671
        • Site Reference ID/Investigator# 31093
      • Warsaw, Poland, 02-671
        • Site Reference ID/Investigator# 31094
      • Warsaw, Poland, 02-671
        • Site Reference ID/Investigator# 31095
      • Warsaw, Poland, 03-748
        • Site Reference ID/Investigator# 31081
      • Warsaw, Poland, 05-075
        • Site Reference ID/Investigator# 31078
      • Wieliczka, Poland, 32-020
        • Site Reference ID/Investigator# 30986
      • Wroclaw, Poland, 51-318
        • Site Reference ID/Investigator# 31027
      • Wroclaw, Poland, 51-318
        • Site Reference ID/Investigator# 31038
      • Wroclaw, Poland, 52-204
        • Site Reference ID/Investigator# 31062
      • Wroclaw, Poland, 53-008
        • Site Reference ID/Investigator# 31070
      • Wroclaw, Poland, 53-020
        • Site Reference ID/Investigator# 31077
      • Wroclaw, Poland, 53-301
        • Site Reference ID/Investigator# 31072
      • Zabrze, Poland, 41-800
        • Site Reference ID/Investigator# 31098
      • Zamosc, Poland, 22-400
        • Site Reference ID/Investigator# 30996
      • Zlotniki, Poland, 46-061
        • Site Reference ID/Investigator# 31073
      • Zory, Poland, 44-240
        • Site Reference ID/Investigator# 30981
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49017
        • Site Reference ID/Investigator# 31108
      • Dnepropetrovsk, Ukraine, 49017
        • Site Reference ID/Investigator# 31109
      • Donetsk, Ukraine, 83000
        • Site Reference ID/Investigator# 31111
      • Kharkov, Ukraine, 61070
        • Site Reference ID/Investigator# 31112
      • Kharkov, Ukraine, 61070
        • Site Reference ID/Investigator# 31113
      • Kharkov, Ukraine, 61070
        • Site Reference ID/Investigator# 31114
      • Kiev, Ukraine, 01030
        • Site Reference ID/Investigator# 31209
      • Kiev, Ukraine, 03022
        • Site Reference ID/Investigator# 31110
      • Kiev, Ukraine, 04107
        • Site Reference ID/Investigator# 21103
      • Kiev, Ukraine, 04107
        • Site Reference ID/Investigator# 31107
      • Simferopol', Ukraine, 95017
        • Site Reference ID/Investigator# 31115

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Age > 50 years
  • Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer, confirmed by histological examination
  • Presence of lower urinary tract symptoms (LUTS)-IPSS >0
  • Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as to Lucrin® Depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice.
  • Until inclusion into PMOS the patient has not been treated with GnRH analogue.
  • The patient, before inclusion into the study, has not been treated by surgery (radical prostatectomy).

Exclusion Criteria:

  • Patients will not be included into the study if any contraindications to treatment with Lucrin® Depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient.
  • Physician or patient can stop treatment at any moment, if any indications or reasons exist.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adv. PCa patients with LUTS treated with GnRH analogue
Patients with advanced prostate cancer and lower urinary tract symptoms treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine.
Other Names:
  • Lupron Depot/Leuprolide acetate 11.25 mg
  • Lucrin Depot 11.25 mg
  • Lupron Depot/Leuprolide acetate 3.75 mg
  • Lucrin Depot 3.75 mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.
Time Frame: Baseline to 12 months
The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Baseline to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
Time Frame: Baseline to 3, 6, 9, and 12 months.
The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Baseline to 3, 6, 9, and 12 months.
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Time Frame: Baseline
Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.
Baseline
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Time Frame: Baseline to 3, 6, 9, and 12 months.
Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.
Baseline to 3, 6, 9, and 12 months.
Reported Adverse Events/Serious Adverse Events
Time Frame: Baseline to 12 months
Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fraktal.com.pl
Med-net.pl

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jozef Haczynski, MD, PhD, Abbott Laboratories, Poland

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P10-612

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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