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SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women

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ClinicalTrials.gov Identifier: NCT01185782
Recruitment Status : Completed
First Posted : August 20, 2010
Results First Posted : February 24, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
Merck Serono Co., Ltd., Japan
Information provided by (Responsible Party):
Merck KGaA

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions: Infertility
Ovulation Induction
Interventions: Drug: Gonalef® (Follitropin alfa)
Drug: Purified pituitary gonadotropin (Fertinorm-P®)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited in 21 study centers in Japan from 15 February 2007 to 25 December 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
300 participants were enrolled in the study; 39 participants discontinued prior to Investigational Medicinal Product (IMP) administration (35 participants for no longer meeting the eligibility criteria 4 due to Adverse Events [AEs] or other reasons). Demographic data was not available for the 4 participants who were randomized but not treated.

Reporting Groups
  Description
SJ-0021 SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
u-hFSH Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.

Participant Flow:   Overall Study
    SJ-0021   u-hFSH
STARTED   129   136 
Treated   129   132 
COMPLETED   123   125 
NOT COMPLETED   6   11 
Adverse Event                0                1 
Protocol Violation                1                0 
Poor Response to Treatment                3                1 
Other                2                5 
Randomized but not treated                0                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SJ-0021 SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
u-hFSH Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
Total Total of all reporting groups

Baseline Measures
   SJ-0021   u-hFSH   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   132   261 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.6  (3.8)   31.6  (3.8)   31.6  (3.8) 
Gender 
[Units: Participants]
     
Female   129   132   261 
Male   0   0   0 
Previous episodes of Ovarian hyperstimulation syndrome (OHSS) [1] 
[Units: Participants]
     
 116   119   235 
 9   10   19 
 2   3   5 
 1   0   1 
 1   0   1 
[1] OHSS is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Episodes of OHSS are presented as values from 0 to 4 where 0 = no episodes to 4 = four episodes.


  Outcome Measures

1.  Primary:   Percentage of Participants With Ovulation   [ Time Frame: On Day 6±1 or 9±1 days during post-treatment assessment period (Day 35-42 of post-treatment period for clinical pregnancy)] ]

2.  Secondary:   Number of Participants With the Dominant Follicle Achieving 18 mm in Mean Diameter   [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]

3.  Secondary:   Time for Dominant Follicle to Achieve 18 mm in Mean Diameter   [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]

4.  Secondary:   Total Dose of the Investigational Medicinal Product (IMP) Administered to Participants With Dominant Follicle Achieving 18 mm in Mean Diameter   [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]

5.  Secondary:   Human Chorionic Gonadotropin (hCG) Cancellation Rate   [ Time Frame: Day 1 of post-treatment assessment period ]

6.  Secondary:   Single Follicle Maturation Rate   [ Time Frame: Start of treatment period until Day 1 of post-treatment assessment period ]

7.  Secondary:   Biochemical Pregnancy Rate   [ Time Frame: Day 28-31 of post-treatment assessment period ]

8.  Secondary:   Clinical Pregnancy Rate   [ Time Frame: Day 35-42 of post-treatment assessment period ]

9.  Secondary:   Ovulation Rate, Where Ovulation is Defined as a Serum P4 Level Greater Than or Equal to 10 ng/mL or Clinical Pregnancy   [ Time Frame: On Day 6±1 or 9±1 during post-treatment assessment period ]

10.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Study Drug Discontinuation   [ Time Frame: Pretrial observation period to post-treatment assessment period (Days 35-42) ]

11.  Secondary:   Number of Participants With OHSS   [ Time Frame: Start of treatment period to post-treatment assessment period (Day 35-42) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono Co., Ltd., Japan, an affiliate of Merck KGaA, Darmstadt, Germany
phone: +49-6151-72-5200
e-mail: service@merckgroup.com


Publications of Results:

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01185782     History of Changes
Obsolete Identifiers: NCT00467480
Other Study ID Numbers: IMP26648
First Submitted: August 11, 2010
First Posted: August 20, 2010
Results First Submitted: September 26, 2011
Results First Posted: February 24, 2012
Last Update Posted: December 27, 2013