Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029) (PURSUE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01144416
First received: June 11, 2010
Last updated: November 10, 2014
Last verified: November 2014
Results First Received: November 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infertility
Interventions: Biological: SCH 900962 / Corifollitropin alfa / Org 36286
Biological: RecFSH / follitropin beta
Drug: Placebo for SCH 900962
Drug: Placebo for recFSH

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women, aged between 35 and 42 years, with an indication for controlled ovarian stimulation and in vitro fertilization/intracytoplasmic sperm injection without a history of previous hyper or low ovarian response to follicle-stimulating hormone/human menopausal gonadotropins, ovarian hyperstimulation syndrome (OHSS), or polycystic ovary syndrome.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1424 participants were originally enrolled in the study. All data for 1 participant, who was incorrectly randomized and did not receive study medication and for all 33 participants at 1 clinical site were excluded from all analyses, including disposition, prior to unblinding. Only women who became pregnant continued into Pregnancy Follow-up period.

Reporting Groups
  Description
Single Injection of 150 µg SCH 900962/MK-8962 Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
Daily 300 IU recFSH Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7

Participant Flow for 2 periods

Period 1:   Intervention Period
    Single Injection of 150 µg SCH 900962/MK-8962     Daily 300 IU recFSH  
STARTED     694     696  
COMPLETED     632     647  
NOT COMPLETED     62     49  
Adverse Event                 5                 6  
Insufficient ovarian response                 11                 17  
Risk of OHSS                 0                 1  
Too high ovarian response                 4                 2  
No/too few/bad oocytes                 7                 5  
No or abnormal fertilization                 25                 10  
No/too few/bad quality embryos                 3                 3  
Unknown                 7                 5  

Period 2:   Pregnancy Follow-up Period
    Single Injection of 150 µg SCH 900962/MK-8962     Daily 300 IU recFSH  
STARTED     154 [1]   167 [2]
COMPLETED     146     157  
NOT COMPLETED     8     10  
[1] Participants received 150 ug SCH 900962 in Intervention Period and became pregnant.
[2] Participants received daily injections of 300 IU recFSH in Intervention Period and became pregnant.



  Baseline Characteristics
  Hide 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
Single Injection of 150 µg SCH 900962/MK-8962 Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
Daily 300 IU recFSH Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
Total Total of all reporting groups

Baseline Measures
    Single Injection of 150 µg SCH 900962/MK-8962     Daily 300 IU recFSH     Total  
Number of Participants  
[units: participants]
  694     696     1390  
Age  
[units: years]
Mean ± Standard Deviation
  38.0  ± 2.2     38.0  ± 2.2     38.0  ± 2.2  
Gender  
[units: participants]
     
Female     694     696     1390  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With a Vital Pregnancy   [ Time Frame: Vital pregnancy will be assessed by ultrasound at least 35 days after embryo transfer (with a timeframe of 35-42 days). Time from start of study treatment to embryo transfer is maximally 24 days. ]

2.  Secondary:   Number of Oocytes Retrieved Per Attempt   [ Time Frame: Maximally 21 days after the start of study treatment. ]

3.  Secondary:   Live Birth Rate   [ Time Frame: Approximately nine months after embryo transfer ]

4.  Secondary:   Number of Participants With Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)   [ Time Frame: Up to approximately 1 month after oocyte pick-up ]

5.  Secondary:   Number of Participants Who Cancelled the Cycle Due to a (Serious) Adverse Event   [ Time Frame: Up to time of embryo transfer (maximum of 24 days after start of study drug) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01144416     History of Changes
Other Study ID Numbers: P06029
Study First Received: June 11, 2010
Results First Received: November 27, 2012
Last Updated: November 10, 2014
Health Authority: United States: Food and Drug Administration