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TerminatedNCT01242748Updated Jun 3, 2015Results posted

A Degarelix Trial in Patients With Prostate Cancer

A Phase 3 interventional study of Degarelix and Goserelin acetate in Prostate Cancer, sponsored by Ferring Pharmaceuticals. Terminated at 63 sites in 13 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-03.

Sponsored by Ferring Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.
Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

Read the detailed description

CS35A was an open-label, multicentre, comparative non-inferiority extension trial to the Phase 3 CS35 trial (NCT00946920).

In the main CS35 trial, participants were randomised 2:1 to treatment with degarelix or goserelin, respectively. All participants who completed the main CS35 trial after initiation of the CS35A trial were eligible to enrol into this extension trial, provided that their treatment could continue uninterrupted. Patients entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).

It was intended that patients enrolled in the CS35A trial would receive treatment with degarelix or goserelin at 3-month intervals for a period of 40 months (including 13 months' treatment in CS35). It was, however, decided to prematurely terminate the CS35A trial due to an insufficient number of patients being enrolled. Maximum exposure of treatment was 111 weeks (in both treatment arms).

The baseline characteristics are based on the CS35A Full Analysis Set (FAS)defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35A and had at least one efficacy assessment after dosing. All efficacy analyses were performed for the CS35/CS35A FAS defined as all participants who received at least one dose of degarelix or goserelin acetate during CS35 and had at least one efficacy assessment after dosing. All safety analyses were performed for the CS35/CS35A Safety analysis set, which included all patients who received at least one dose of degarelix or goserelin acetate during CS35.

02

Conditions studied

  • Prostate Cancer

Browse trials for

03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.

This study's enrollment of 288 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Has given written consent prior to any trial-related activity is performed. (A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
  • Has completed the CS35 trial.

Exclusion criteria

Exclusion Criteria:

  • Has been withdrawn from the CS35 trial.
  • Has had end of trial visit in CS35 prior to approval of the CS35A protocol.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (actual)

Study arms

  • Experimental
    Degarelix 240 mg/480 mg

    Drug: Degarelix

  • Active comparator
    Goserelin acetate

    Drug: Goserelin acetate

Interventions

  • DrugDegarelix

    The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.

    Also known as: Firmagon, FE200486

  • DrugGoserelin acetate

    The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.

    Also known as: Zoladex

06

What researchers measure

Primary outcomes

  1. Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin

    PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.

    Time frame: From baseline to 3 years

Secondary outcomes

  1. Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

    PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.

    Time frame: From baseline to 3 years

  2. Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

    PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.

    Time frame: From baseline to 3 years

  3. Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin

    Testosterone escape is defined as serum levels \>0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.

    Time frame: From baseline to 3 years

  4. Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin

    Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.

    Time frame: From baseline to 3 years

  5. Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin

    The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.

    Time frame: From baseline to 3 years

  6. Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin

    Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

    Time frame: Baseline and after 1, 6, 12, 19, and 22 months

  7. Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin

    Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

    Time frame: Baseline and after 1, 6, 12, 19, and 22 months

07

Results

Posted Jun 3, 2015

Participant flow

All participants who completed the main CS35 trial after initiation of the CS35A extension trial were eligible to enrol into CS35A.

Participant flow — Overall Study
MilestoneDegarelix 240 mg/480 mgGoserelin Acetate
Started19494
Cs35/cs35a safety analysis set565283
Cs35/cs35a full analysis set (fas)565282
Completed15680
Not completed3814
Withdrew: Adverse event105
Withdrew: Lost to follow-up62
Withdrew: Physician decision32
Withdrew: Protocol violation10
Withdrew: Withdrawal by subject102
Withdrew: Miscellaneous reasons83

Outcome measures

PrimaryHazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin

PSA PFS failure is defined as either PSA failure (defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart) or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA-PFS.

Time frame:
From baseline to 3 years
Reported as:
Number · percentage of no PSA-PFS
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin
percentage of no PSA-PFSDegarelix 240 mg/480 mgGoserelin Acetate
Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years' Treatment Between Degarelix and Goserelin75.5 (69.1 to 80.7)75.4 (64.5 to 83.4)
Statistical analysis
  • Degarelix 240 mg/480 mg vs Goserelin Acetate · Cox proportional hazard model · p = 0.1589 · Hazard ratio (hr): 0.774 · 95% CI 0.542 to 1.106
SecondaryHazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

PFS failure is defined as either PSA failure, introduction of additional therapy related to prostate cancer (radiation, anti-androgens or second-line treatment), or death, whichever is first. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PFS failure.

Time frame:
From baseline to 3 years
Reported as:
Number · percentage of no PFS failure
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
percentage of no PFS failureDegarelix 240 mg/480 mgGoserelin Acetate
Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin71.5 (66.0 to 76.2)69.0 (58.0 to 77.7)
Statistical analysis
  • Degarelix 240 mg/480 mg vs Goserelin Acetate · Cox proportional hazard model · p = 0.1244 · Hazard ratio (hr): 0.783 · 95% CI 0.574 to 1.070
SecondaryHazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin

PSA failure is defined as increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no PSA failure.

Time frame:
From baseline to 3 years
Reported as:
Number · percentage of no PSA failure
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin
percentage of no PSA failureDegarelix 240 mg/480 mgGoserelin Acetate
Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin77.5 (71.0 to 82.7)79.6 (68.9 to 86.9)
Statistical analysis
  • Degarelix 240 mg/480 mg vs Goserelin Acetate · Hazard ratio (hr): 0.856 · 95% CI 0.580 to 1.263
SecondaryHazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin

Testosterone escape is defined as serum levels \>0.5 ng/mL. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no testosterone escape.

Time frame:
From baseline to 3 years
Reported as:
Number · percentage of no testosterone escape
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin
percentage of no testosterone escapeDegarelix 240 mg/480 mgGoserelin Acetate
Hazard Ratio of Testosterone Escape Rates During 3 Years' Treatment Between Degarelix and Goserelin83.7 (77.4 to 88.4)96.7 (93.7 to 98.2)
Statistical analysis
  • Degarelix 240 mg/480 mg vs Goserelin Acetate · Cox proportional hazard model · p = 0.0005 · Hazard ratio (hr): 3.511 · 95% CI 1.739 to 7.090
SecondaryHazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin

Additional therapy related to prostate cancer included radiation, anti-androgens and second-line treatment. The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of no additional therapy related to prostate cancer.

Time frame:
From baseline to 3 years
Reported as:
Number · percentage of no additional therapy
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin
percentage of no additional therapyDegarelix 240 mg/480 mgGoserelin Acetate
Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years' Treatment Between Degarelix and Goserelin84.5 (80.0 to 88.1)83.4 (77.3 to 88.0)
Statistical analysis
  • Degarelix 240 mg/480 mg vs Goserelin Acetate · Cox proportional hazard model · p = 0.143 · Hazard ratio (hr): 0.739 · 95% CI 0.493 to 1.108
SecondaryHazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin

The number below present the unadjusted rates (estimated using the Kaplan-Meier method) of death.

Time frame:
From baseline to 3 years
Reported as:
Number · percentage of deaths
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin
percentage of deathsDegarelix 240 mg/480 mgGoserelin Acetate
Hazard Ratio of Mortality Rates During 3 Years' Treatment Between Degarelix and Goserelin4.6 (2.4 to 8.5)5.3 (2.6 to 10.5)
Statistical analysis
  • Degarelix 240 mg/480 mg vs Goserelin Acetate · Cox proportional hazard model · p = 0.2212 · Hazard ratio (hr): 0.595 · 95% CI 0.259 to 1.368
SecondarySerum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin

Median testosterone levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

Time frame:
Baseline and after 1, 6, 12, 19, and 22 months
Reported as:
Median · ng/mL
Serum Levels of Testosterone During 3 Years' Treatment With Degarelix or Goserelin
ng/mLDegarelix 240 mg/480 mgGoserelin Acetate
Baseline4.52 (0.56 to 14.5)4.62 (0.07 to 13.2)
Month 10.10 (0.015 to 3.85)0.16 (0.04 to 1.77)
Month 60.09 (0.015 to 1.57)0.09 (0.015 to 0.32)
Month 120.10 (0.015 to 1.1)0.09 (0.015 to 0.44)
Month 190.11 (0.05 to 2.22)0.05 (0.05 to 0.43)
Month 220.11 (0.05 to 3.4)0.05 (0.05 to 0.23)
SecondarySerum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin

Median PSA levels are presented as absolute values in nanograms per milliliter (ng/mL) at baseline and after 1, 6, 12, 19, and 22 months. One month equals 28 days. After 22 months, only a limited number of samples were analysed.

Time frame:
Baseline and after 1, 6, 12, 19, and 22 months
Reported as:
Median · ng/mL
Serum Levels of Prostate-specific Antigen (PSA) During 3 Years' Treatment With Degarelix or Goserelin
ng/mLDegarelix 240 mg/480 mgGoserelin Acetate
Baseline19 (0.26 to 8762)19.1 (0.005 to 12961)
Month 13.79 (0.03 to 1540)6.5 (0.005 to 645)
Month 60.82 (0.005 to 2648)0.73 (0.005 to 607)
Month 120.6 (0.005 to 6889)0.43 (0.005 to 1802)
Month 190.54 (0.005 to 712)0.28 (0.005 to 1150)
Month 220.535 (0.005 to 252)0.26 (0.005 to 646)

Adverse events

Collected over Adverse events were recorded from signed informed consent until the last visit (maximum 111 weeks of treatment).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Degarelix 240 mg/480 mg—58/565 (10.3%)430/565 (76.1%)
Goserelin Acetate—33/283 (11.7%)197/283 (69.6%)
Most frequent serious events
Showing 10 of 114
Most frequent serious events
EventDegarelix 240 mg/480 mgGoserelin Acetate
Pulmonary embolismRespiratory, thoracic and mediastinal disorders4/5653/283
AnaemiaBlood and lymphatic system disorders2/5652/283
Acute myocardial infarctionCardiac disorders2/5652/283
Supraventricular tachycardiaCardiac disorders0/5652/283
Lobar pneumoniaInfections and infestations1/5652/283
PneumoniaInfections and infestations1/5652/283
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/5652/283
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders2/5652/283
Gastrointestinal haemorrhageGastrointestinal disorders3/5650/283
Sudden deathGeneral disorders3/5650/283
Most frequent other events
Showing 10 of 12
Most frequent other events
EventDegarelix 240 mg/480 mgGoserelin Acetate
Injection site painGeneral disorders174/5654/283
Hot flushVascular disorders161/56576/283
Injection site erythemaGeneral disorders123/5650/283
Injection site noduleGeneral disorders52/5650/283
Weight increasedInvestigations27/56524/283
Back painMusculoskeletal and connective tissue disorders23/56523/283
HypertensionVascular disorders23/56520/283
Injection site swellingGeneral disorders36/5650/283
Urinary tract infectionInfections and infestations26/56518/283
Oedema peripheralGeneral disorders13/56516/283

Baseline characteristics

CS35A Full Analysis Set

Age, Continuous
Age, Continuous(years)Degarelix 240 mg/480 mgGoserelin AcetateTotal
Mean73.1 ± 8.471.3 ± 7.072.5 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)Degarelix 240 mg/480 mgGoserelin AcetateTotal
Female000
Male19494288
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Degarelix 240 mg/480 mgGoserelin AcetateTotal
American Indian or Alaska Native342155
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American5510
White15468222
More than one race000
Unknown or Not Reported000
Median Baseline Serum Testosterone Levels
Median Baseline Serum Testosterone Levels(nanogram per milliliter (ng/mL))Degarelix 240 mg/480 mgGoserelin AcetateTotal
Median4.41 (0.68 to 13.3)4.65 (1.55 to 13.2)4.52 (0.68 to 13.3)
Median Baseline Serum Prostate-specific Antigen Levels
Median Baseline Serum Prostate-specific Antigen Levels(ng/mL)Degarelix 240 mg/480 mgGoserelin AcetateTotal
Median20.6 (0.4 to 8762)16.6 (1.49 to 12961)18.7 (0.4 to 12961)
08

Study locations

63 sites
  • University of Colorado School of Medicine
    Aurora, Colorado, United States
  • The Urology Center of Colorado
    Denver, Colorado, United States
  • Urology Associates of Dover, PA
    Dover, Delaware, United States
  • South Florida Medical Research
    Aventura, Florida, United States
  • Urology Group of New Mexico, PC
    Albuquerque, New Mexico, United States
  • Carolina Urologic Research Center
    Myrtle Beach, South Carolina, United States
  • Urology San Antonio Research, Pa
    San Antonio, Texas, United States
  • Seattle Urology Research Center
    Burien, Washington, United States
  • AZ Groeninge - Campus Sint-Maarten
    Kortrijk, Belgium
  • Jonathan Giddens Medicine Professional Corporation
    Brampton, Ontario, Canada
  • Southern Interior Medical Research Inc.
    Kelowna, Canada
  • Mor Urology, Inc.
    Newmarket, Canada
  • Investigational site
    Scarborough, Canada
  • Investigational site
    Toronto, Canada
  • Urocentrum Brno
    Brno, Czech Republic
  • Nemocnice Jindrichuv Hradec, a.s.
    Jindrichuv Hradec, Czech Republic
  • Kromerizska nemocnice a.s.
    Kromeriz, Czech Republic
  • Fakultni nemocnice v Motole, Praha 5
    Praha, Czech Republic
  • Vseobecna fakultni nemocnice v Praze, Praha 2
    Praha, Czech Republic
  • Krajska nemocnice T. Bati a.s.
    Zlin, Czech Republic
  • ODL Terveys Oy
    Oulu, Finland
  • Pohjois-Karjalan keskussairaala
    Tampere, Finland
  • Tampereen yliopistollinen sairaala
    Tampere, Finland
  • Gemeinschaftspraxis Rudolph & Wörner
    Kirchheim, Germany
  • Urologische Studienpraxis
    Nürtingen, Germany
  • Fövárosi Önkormányzat Bajcsy-Zsilinszky Kórház
    Budapest, Hungary
  • Fövárosi Önkormányzat uzsoki utcai Kórház
    Budapest, Hungary
  • Semmelweis Egyetem
    Budapest, Hungary
  • Dombóvári Szent Lukács Egészségügyi Nonprofit Kft.
    Dombóvár, Hungary
  • Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
    Miskolc, Hungary
  • Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft
    Miskolc, Hungary
  • Pécsi Tudományegyetem
    Pécs, Hungary
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
    Szeged, Hungary
  • Jávorszky Ödön Kórház
    Vác, Hungary
  • Hospital Christus Muguerza del Parque
    Chihuahua, Chih., Mexico
  • Hospital Angeles Culiacan
    Culiacan, Sinaloa, Mexico
  • Consultorio de Especialidad en Urologia Privado
    Durango, Mexico
  • Hospital Angeles Lindavista
    Mexico City, DF, Mexico
  • Médica Sur, S.A.B. de C.V.
    Mexico City, Mexico
  • Consultorio Medico
    Zapopan, Jalisco, Mexico
  • MC Haaglanden
    Den Haag, Netherlands
  • Catharina-ziekenhuis
    Eindhoven, Netherlands
  • SPZOZ Wojewodzki Szpital Zespolony im. J.Sniadeckiego
    Bialystok, Poland
  • Centrum Medyczne Medur Sp. z o.o.
    Bielsko-Biala, Poland
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku
    Slupsk, Poland
  • Private Medical Center SRL
    Arad, Romania
  • Brasov Emergency Clinical County Hospital
    Brasov, Romania
  • "Prof. Dr. Th. Burghele" Clinical Hospital
    Bucharest, Romania
  • "Sfantul Ioan" Emergency Clinical Hospital
    Bucharest, Romania
  • Dinu Uromedica
    Bucharest, Romania
  • Fundeni Clinical Institute of Uronephrology and Renal Transplantation
    Bucharest, Romania
  • PROVITA 2000 Medical Center
    Constanta, Romania
  • "Dr. C.I. Parhon" Clinical Hospital
    Iasi, Romania
  • Vita Care Flav Medical Center
    Pitesti, Romania
  • Sibiu Emergency Clinical County Hospital
    Sibiu, Romania
  • Dnipropetrovsk State Medical Academy
    Dnipropetrovsk, Ukraine
  • Donetsk Regional Clinical Territorial Medical Association
    Donetsk, Ukraine
  • Regional Clinical Center of Urology and Nephrology n.a. V.I.Shapoval
    Kharkiv, Ukraine
  • Kyiv City Clinical Hospital #3
    Kyiv, Ukraine
  • Odesa Regional Clinical Hospital
    Odesa, Ukraine
  • Municipal Institution "Zaporizhzhia Regional Clinical Hospital"
    Zaporizhzhya, Ukraine
  • Ipswich Hospital
    Ipswich, United Kingdom
  • The Royal Marsden NHS Foundation Trust
    Sutton, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01242748
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 17, 2010
Start date
Oct 2010
Primary completion
Dec 2011
Completion
Jan 2012
Results posted
Jun 3, 2015
Last update
Jun 3, 2015

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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