A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

This study has been completed.

Sponsor:

Information provided by:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00257556

First received: November 22, 2005

Last updated: February 12, 2010

Last verified: February 2010

History of Changes

Results First Received: January 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Infertility
Interventions:	Drug: Menotrophin Drug: Follitropin alfa

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
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Ninety (90) participants were screened and 80 participants randomized.

Reporting Groups

	Description
Menotrophin	Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
Follitropin Alfa	A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).

Participant Flow: Overall Study

	Menotrophin	Follitropin Alfa
STARTED	38	42
All Patients Treated Population	37 ^[1]	39 ^[2]
COMPLETED	24	32
NOT COMPLETED	14	10
Adverse Event	1	4
Physician Decision	6	0
Did not meet hCG criterion	3	0
other reason	4	6

[1]	Also the safety population. One randomized patient did not receive study medication.
[2]	Also the safety population. Three randomized patients did not receive study medication.

Baseline Characteristics

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Reporting Groups

	Description
Menotrophin	Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
Follitropin Alfa	A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
Total	Total of all reporting groups

Baseline Measures

	Menotrophin	Follitropin Alfa	Total
Number of Participants [units: participants]	37	39	76
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	37	39	76
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	30.7 ± 3.45	30.9 ± 2.67	30.8 ± 3.06
Gender [units: participants]
Female	37	39	76
Male	0	0	0
Tobacco Use [units: participants]
Smoker	4	8	12
Ex-smoker	8	5	13
Never Smoked	25	26	51
Body Mass Index ^[1] [units: Kilograms/Meters squared] Mean ± Standard Deviation	24.02 ± 3.689	23.81 ± 3.731	23.91 ± 3.687
Diastolic Blood Pressure [units: mm Hg] Mean ± Standard Deviation	74.1 ± 8.83	73.8 ± 9.96	74.0 ± 9.37
Pulse [units: beats per minute] Mean ± Standard Deviation	75.7 ± 9.63	74.5 ± 9.16	75.1 ± 9.35
Systolic Blood Pressure [units: mm Hg] Mean ± Standard Deviation	115.3 ± 12.50	116.1 ± 14.55	115.7 ± 13.51

[1]	Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women

Outcome Measures

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1. Primary:

Number of Participants With an Ongoing Pregnancy [ Time Frame: Approx week 13; 9 weeks or more after the 1st positive pregnancy test ]

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2. Primary:

Percentage of Participants With an Ongoing Pregnancy [ Time Frame: Approx week 13; 9 weeks or more after the first positive pregnancy test ]

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3. Secondary:

Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters [ Time Frame: Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) ]

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4. Secondary:

Participants With Varying Numbers of Oocytes Retrieved [ Time Frame: Approximately study day 15 ]

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5. Secondary:

Participants With Varying Numbers of Pronuclear Stage Oocytes [ Time Frame: Approximately study day 15 ]

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6. Secondary:

Participants With Varying Numbers of Embryos Transferred [ Time Frame: Approximately study day 17 ]

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7. Secondary:

Participants With Varying Numbers of Embryos Frozen [ Time Frame: Approximately study day 17 ]

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8. Secondary:

Mean Number of Days Stimulated With Gonadotrophins [ Time Frame: study days 1 - 13 ]

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9. Secondary:

Pregnancy Outcomes [ Time Frame: Approximately 10 months ]

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10. Secondary:

Mean Endometrial Thickness [ Time Frame: Day 7 or 9 or 11 or 13 ]

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11. Secondary:

Mean Estradiol Level [ Time Frame: Day 7 or 9 or 11 or 13 ]

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Serious Adverse Events

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Time Frame	No text entered.
Additional Description	The 'all patients treated' population is the same as the safety population in this study.

Reporting Groups

	Description
Menotrophin	Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
Follitropin Alfa	A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).

Serious Adverse Events

	Menotrophin	Follitropin Alfa
Total, serious adverse events
# participants affected / at risk	4/37 (10.81%)	9/39 (23.08%)
Gastrointestinal disorders
Abdominal Pain ^{† 1}
# participants affected / at risk	0/37 (0.00%)	2/39 (5.13%)
Abdominal Pain Lower ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)
Constipation ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)
Vomiting ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)
General disorders
Pyrexia ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous ^{† 1}
# participants affected / at risk	1/37 (2.70%)	3/39 (7.69%)
Abortion Imminent ^{† 1}
# participants affected / at risk	1/37 (2.70%)	0/39 (0.00%)
Renal and urinary disorders
Dysuria ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)
Reproductive system and breast disorders
Ovarian Hyperstimulation Syndrome ^{† 1}
# participants affected / at risk	2/37 (5.41%)	3/39 (7.69%)
Uterine Haemorrhage ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)
Vaginal Haemorrhage ^{† 1}
# participants affected / at risk	0/37 (0.00%)	1/39 (2.56%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 7.1

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 only disclosure restiction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.

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: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com

No publications provided

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00257556 History of Changes
Other Study ID Numbers:	FE999906 CS004 (PROSPECT), 2004-001307-35
Study First Received:	November 22, 2005
Results First Received:	January 8, 2010
Last Updated:	February 12, 2010
Health Authority:	United Kingdom: National Health Service Germany: Ethics Commission

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