Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01497197
Recruitment Status : Terminated (Study was terminated as per sponsor's decision)
First Posted : December 22, 2011
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
Merck Serono Middle East FZ LLC
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Infertility
Fertility
Follicle Stimulating Hormone Deficiency
Interventions Drug: GONAL-f®
Drug: Luveris®
Biological: Recombinant human chorionic gonadotropin (r-hCG)
Enrollment 174
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice. GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
Period Title: Overall Study
Started 89 85
Completed 72 70
Not Completed 17 15
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             0             2
Withdrawal by Subject             2             1
Excessive/lack of response to treatment             1             0
Risk of OHSS             1             0
No oocytes retrieved             3             2
No fertilisation             6             5
Intention to freeze all embryos             0             1
All embryos discarded             0             3
Other             3             1
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris Total
Hide Arm/Group Description GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. Total of all reporting groups
Overall Number of Baseline Participants 89 85 174
Hide Baseline Analysis Population Description
Baseline analysis population included all the subjects randomized in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 85 participants 174 participants
37.8  (1.6) 38  (1.7) 37.9  (1.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 85 participants 174 participants
Female
89
 100.0%
85
 100.0%
174
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Total Number of Oocytes Retrieved Per Subject Following Ovarian Stimulation
Hide Description Ovarian stimulation was performed using in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The total number of oocytes collected per subject following stimulation was reported.
Time Frame 34-38 hours post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intention-to-treat (MITT) included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following recombinant human follicle stimulating hormone (r-hFSH) stimulation and r-hCG injection).
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: oocytes
8.6  (6.54) 8.7  (5.77)
2.Secondary Outcome
Title Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Hide Description Mean daily dose of FSH was to be determined by dividing the total daily dose by the number of stimulation days.
Time Frame Screening
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analysed as per planned analysis due to frequent protocol violations/deviations, there was no subject eligible to be analyzed per protocol.
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Total Number of Stimulation Treatment Days
Hide Description The total number of stimulation treatment days for each subject was determined based on the treatment administration information collected in the case report form.
Time Frame 6 days post stimulation (Number of stimulation days+6 days)
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 86 82
Mean (Standard Deviation)
Unit of Measure: days
11.1  (2.42) 11.3  (2.24)
4.Secondary Outcome
Title Implantation Rate
Hide Description The implantation rate was determined as number of fetal sacs divided by the number of embryos transferred post r-hCG administration.
Time Frame 35-42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: fetal sacs/embryo transferred
0.5  (0.51) 0.4  (0.51)
5.Secondary Outcome
Title Number of Fetal Sacs With Activity
Hide Description Number of fetal sacs with activity was evaluated by ultrasound scan (US) on Days 35–42 post r-hCG to confirm clinical pregnancy.
Time Frame 35-42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Fetal sacs
0.8  (0.42) 1.1  (0.54)
6.Secondary Outcome
Title Number of Fetal Sacs With Detectable Heart Beats
Hide Description Number of fetal sacs with detectable heart beats was evaluated by US on Days 35-42 post r-hCG to confirm clinical pregnancy
Time Frame 35-42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all subjects randomized in the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed primary efficacy assessment(total number of oocytes retrieved/subject following r-hFSH stimulation and r-hCG injection). 'N' signifies all participants who showed positive pregnancy test and evaluable for this outcome measure.
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 19 21
Mean (Standard Deviation)
Unit of Measure: Fetal sacs
0.6  (0.50) 1.0  (0.45)
7.Secondary Outcome
Title Total Pregnancy Rate and Clinical Pregnancy Rate
Hide Description The subject was considered to have a positive pregnancy result if beta-hCG >10 international units per liter (IU/L) and the subject had not menstruated between post-r-hCG Days 15–20. Clinical pregnancy was defined as the existence of at least an US confirmed gestational sac in the uterus with fetal heart activity post-r-hCG Days 35–42.
Time Frame 35-42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: percentage of subjects
Total pregnancy 20 27
Clinical pregnancy 17 23
8.Secondary Outcome
Title Cycle Cancellation Rate Prior to r-hCG
Hide Description If the subject was not administered with r-hCG and withdrew prematurely from the trial, it was considered as cycle cancellation.
Time Frame Up to 85 days
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: percentage of subjects
0 0
9.Secondary Outcome
Title Number of Subjects With Biochemical Pregnancies
Hide Description Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Subjects with beta-hCG concentration greater than 10 IU/L were considered as biochemical pregnant.
Time Frame 35 to 42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all the subjects randomized into the trial who received at least 1 dose of Gonal-f® or Luveris®, and who completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection).
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 86 82
Measure Type: Number
Unit of Measure: subjects
2 1
10.Secondary Outcome
Title Number of Subjects With Multiple Pregnancies
Hide Description Multiple pregnancy was defined as the existence of more than one ultrasound confirmed gestational sac in the uterus with fetal heart activity at post-r-hCG Days 35–42.
Time Frame 35 to 42 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
MITT included all subjects randomized into trial who received at least 1 dose of Gonal-f® or Luveris®, and completed the primary efficacy assessment (total number of oocytes retrieved per subject following r-hFSH stimulation and r-hCG injection). ‘N’=signifies all subjects who showed positive pregnancy test and evaluable for this outcome measure.
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 19 21
Measure Type: Number
Unit of Measure: subjects
0 4
11.Secondary Outcome
Title Number of Subjects With Any Adverse Events (AEs), Serious AEs, AEs Leading to Death, and AEs Leading to Discontinuation
Hide Description An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A serious AE is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Time Frame Baseline up to 15-20 days post r-hCG administration
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized subjects who received at least one dose of the trial treatment.
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description:
GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Overall Number of Participants Analyzed 89 85
Measure Type: Number
Unit of Measure: subjects
AEs 27 28
Serious AEs 4 5
AEs Leading to Death 0 0
AEs Leading to Discontinuation 1 3
Time Frame Baseline up to 15-20 days post r-hCG administration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gonal-f®+Luveris Gonal-f® Followed by Luveris
Hide Arm/Group Description GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice. GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
All-Cause Mortality
Gonal-f®+Luveris Gonal-f® Followed by Luveris
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gonal-f®+Luveris Gonal-f® Followed by Luveris
Affected / at Risk (%) Affected / at Risk (%)
Total   4/89 (4.49%)   5/85 (5.88%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  2/89 (2.25%)  4/85 (4.71%) 
Reproductive system and breast disorders     
Ovarian cyst * 1  2/89 (2.25%)  1/85 (1.18%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gonal-f®+Luveris Gonal-f® Followed by Luveris
Affected / at Risk (%) Affected / at Risk (%)
Total   24/89 (26.97%)   27/85 (31.76%) 
Injury, poisoning and procedural complications     
Overdose * 1  13/89 (14.61%)  14/85 (16.47%) 
Investigations     
Oestradiol increased * 1  8/89 (8.99%)  8/85 (9.41%) 
Progesterone increased * 1  0/89 (0.00%)  1/85 (1.18%) 
Metabolism and nutrition disorders     
Hyperglycaemia * 1  0/89 (0.00%)  1/85 (1.18%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  2/89 (2.25%)  5/85 (5.88%) 
Reproductive system and breast disorders     
Breast pain * 1  1/89 (1.12%)  0/85 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Study was terminated as per sponsor's decision.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01497197     History of Changes
Other Study ID Numbers: EMR200061-506
First Submitted: December 20, 2011
First Posted: December 22, 2011
Results First Submitted: June 15, 2015
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015