Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029 AM1) (PURSUE)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01144416

First received: June 11, 2010

Last updated: May 8, 2013

Last verified: May 2013

History of Changes

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

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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

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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

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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. ]

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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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) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator agreed not to publish or publicly present any interim results of the trial without the prior written consent of the sponsor. The investigator further agreed to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report(s) any results of the trial.

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.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
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:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

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