MENOPUR® Versus FOLLISTIM®

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00802360

First received: December 3, 2008

Last updated: October 31, 2011

Last verified: October 2011

History of Changes

Results First Received: May 3, 2011

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: Menotropin Drug: Progestrone vaginal insert Drug: follitropin beta Drug: Progesterone in oil Drug: Ganirelix

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
One hundred ninety one (191) participants were screened from 6 study centers in the US; 173 of these participants were eligible for randomization. Six subjects did not receive their respected treatment and two subjects withdrew consent, 165 subjects were included in the statistical analyses

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Menopur/Endometrin	Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Menopur/Progesterone in Oil	Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Follistim/Endometrin	Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Follistim/Progesterone in Oil	Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Participant Flow: Overall Study

	Menopur/Endometrin	Menopur/Progesterone in Oil	Follistim/Endometrin	Follistim/Progesterone in Oil
STARTED	42	42	42	39
COMPLETED	18	16	17	17
NOT COMPLETED	24	26	25	22
Stimulation failure	4	0	3	3
Inadequate number of oocytes retrieved	0	0	0	1
Cycle cancelled	0	1	1	1
Risk of ovarian hyperstimulation syndrom	0	0	0	1
No positive serum pregnancy	17	20	14	10
Pregnancy not confirmed by ultrasound	1	0	1	0
Pregnancy loss/miscarriage	0	2	0	3
Unspecified	2	3	6	3

Baseline Characteristics

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Reporting Groups

	Description
Menopur/Endometrin	Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Menopur/Progesterone in Oil	Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Follistim/Endometrin	Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Follistim/Progesterone in Oil	Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Total	Total of all reporting groups

Baseline Measures

	Menopur/Endometrin	Menopur/Progesterone in Oil	Follistim/Endometrin	Follistim/Progesterone in Oil	Total
Number of Participants [units: participants]	42	42	42	39	165
Age [units: years] Mean ± Standard Deviation	33.5 ± 4.1	33.2 ± 4.8	34.0 ± 4.3	33.9 ± 4.3	33.9 ± 7.4
Gender [units: participants]
Female	42	42	42	39	165
Male	0	0	0	0	0
Race/Ethnicity, Customized [units: Participants]
Caucasian	32	35	31	32	130
African American	5	1	2	2	10
Asian	4	2	6	2	14
Hispanic	1	4	3	1	9
Other	0	0	0	2	2
Body Mass Index (BMI) [units: kg/m^2] Mean ± Standard Deviation	24.6 ± 4.1	23.8 ± 3.0	25.0 ± 3.3	25.6 ± 4.5	24.6 ± 3.8
Follicle-stimulating hormone level [units: mIU/mL] Mean ± Standard Deviation	7.4 ± 2.3	7.1 ± 2.2	6.9 ± 2.0	6.9 ± 2.9	7.3 ± 2.3

Outcome Measures

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1. Primary:

Percentage of Participants With Ongoing Pregnancy at Week 8 [ Time Frame: Week 8 (Week 6 of gestation) ]

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2. Secondary:

Number of Follicles Observed at Day 15 [ Time Frame: Day 15 ]

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3. Secondary:

Number of Oocytes Retrieved at Day 18 [ Time Frame: Approximately Day 18 ]

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4. Secondary:

Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved [ Time Frame: Approximately Day 19 ]

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5. Secondary:

Number of Embryos Transferred at Three Stages of Development [ Time Frame: Approximately Day 24 ]

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6. Secondary:

Number of Embryos Frozen at Day 24 [ Time Frame: Approximately Day 24 ]

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7. Secondary:

Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle [ Time Frame: Day 1 to Day 24 ]

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8. Secondary:

Participants With Biochemical Pregnancy at Day 38 [ Time Frame: approximately day 38 (Day 14 post embryo transfer) ]

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9. Secondary:

Participants With Clinical Pregnancy at Week 7 [ Time Frame: approximately week 7 ]

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10. Secondary:

Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: Day 1 - week 12 ]

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11. Secondary:

Number of Live Births [ Time Frame: Approximately 10 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Treatment-emergent adverse events were collected from Day 1 to Week 12.
Additional Description	Multiple events in the same system organ class for a subject are only counted once for that system organ class.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Menopur/Endometrin	Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Menopur/Progesterone in Oil	Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Follistim/Endometrin	Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Follistim/Progesterone in Oil	Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Other Adverse Events

	Menopur/Endometrin	Menopur/Progesterone in Oil	Follistim/Endometrin	Follistim/Progesterone in Oil
Total, other (not including serious) adverse events
# participants affected / at risk	20/42	18/42	18/42	21/39
Gastrointestinal disorders
Abdominal distension ^{† 1}
# participants affected / at risk	4/42 (9.52%)	6/42 (14.29%)	3/42 (7.14%)	5/39 (12.82%)
Abdominal pain lower ^{† 1}
# participants affected / at risk	3/42 (7.14%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Abdominal pain upper ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	2/39 (5.13%)
Nausea ^{† 1}
# participants affected / at risk	3/42 (7.14%)	5/42 (11.90%)	3/42 (7.14%)	8/39 (20.51%)
Abdominal discomfort ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Abdominal pain ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	2/42 (4.76%)	0/39 (0.00%)
Ascites ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Constipation ^{† 1}
# participants affected / at risk	1/42 (2.38%)	1/42 (2.38%)	2/42 (4.76%)	0/39 (0.00%)
Dyspepsia ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Flatulence ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Stomach discomfort ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Vomiting ^{† 1}
# participants affected / at risk	1/42 (2.38%)	2/42 (4.76%)	2/42 (4.76%)	1/39 (2.56%)
General disorders
Adverse drug reaction ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Fatigue ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Injection site discomfort ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Injection site erythema ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Injection site oedema ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Injection site pruritus ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Injection site rash ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Irritability ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Oedema peripheral ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Immune system disorders
Drug hypersensitivity ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Infections and infestations
Fungal infection ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Nasopharyngitis ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	1/39 (2.56%)
Urinary tract infection ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Vulvovaginal mycotic infection ^{† 1}
# participants affected / at risk	1/42 (2.38%)	2/42 (4.76%)	1/42 (2.38%)	1/39 (2.56%)
Injury, poisoning and procedural complications
Procedural pain ^{† 1}
# participants affected / at risk	1/42 (2.38%)	3/42 (7.14%)	5/42 (11.90%)	2/39 (5.13%)
Incision site complication ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Injection site anaesthesia ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Procedural nausea ^{† 1}
# participants affected / at risk	1/42 (2.38%)	1/42 (2.38%)	2/42 (4.76%)	0/39 (0.00%)
Investigations
Alanine aminotransferase increased ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Metabolism and nutrition disorders
Decreased appetite ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^{† 1}
# participants affected / at risk	2/42 (4.76%)	2/42 (4.76%)	0/42 (0.00%)	0/39 (0.00%)
Musculoskeletal pain ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Myalgia ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Nervous system disorders
Dizziness ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	1/42 (2.38%)	2/39 (5.13%)
Headache ^{† 1}
# participants affected / at risk	1/42 (2.38%)	1/42 (2.38%)	2/42 (4.76%)	1/39 (2.56%)
Migraine ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	1/42 (2.38%)	0/39 (0.00%)
Psychiatric disorders
Depression ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Insomnia ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	1/42 (2.38%)	0/39 (0.00%)
Renal and urinary disorders
Bladder pain ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Reproductive system and breast disorders
Adnexa uteri pain ^{† 1}
# participants affected / at risk	6/42 (14.29%)	7/42 (16.67%)	6/42 (14.29%)	9/39 (23.08%)
Ovarian hyperstimulation syndrome ^{† 1}
# participants affected / at risk	3/42 (7.14%)	1/42 (2.38%)	1/42 (2.38%)	8/39 (20.51%)
Pelvic pain ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	2/39 (5.13%)
Breast tenderness ^{† 1}
# participants affected / at risk	2/42 (4.76%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Metrorrhagia ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	1/42 (2.38%)	1/39 (2.56%)
Pelvic discomfort ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Uterine spasm ^{† 1}
# participants affected / at risk	1/42 (2.38%)	1/42 (2.38%)	2/42 (4.76%)	1/39 (2.56%)
Vaginal discharge ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Vaginal haemorrhage ^{† 1}
# participants affected / at risk	2/42 (4.76%)	0/42 (0.00%)	2/42 (4.76%)	0/39 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	0/42 (0.00%)	0/39 (0.00%)
Dyspnoea ^{† 1}
# participants affected / at risk	1/42 (2.38%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Nasal congestion ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	0/42 (0.00%)	1/39 (2.56%)
Pharyngolaryngeal pain ^{† 1}
# participants affected / at risk	2/42 (4.76%)	0/42 (0.00%)	1/42 (2.38%)	1/39 (2.56%)
Sinus congestion ^{† 1}
# participants affected / at risk	0/42 (0.00%)	0/42 (0.00%)	1/42 (2.38%)	0/39 (0.00%)
Skin and subcutaneous tissue disorders
Acne ^{† 1}
# participants affected / at risk	1/42 (2.38%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)
Vascular disorders
Haematoma ^{† 1}
# participants affected / at risk	0/42 (0.00%)	1/42 (2.38%)	0/42 (0.00%)	0/39 (0.00%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA (Unspecified)

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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 restriction 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. Additional time may be required to allow Ferring to seek patent protection of the invention.

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
This was an exploratory study that could be used as the basis for larger, adequately-powered studies. This limitation is the reason no statistical analyses are offered for study outcomes.

Results Point of Contact:

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

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00802360 History of Changes
Other Study ID Numbers:	2008-04
Study First Received:	December 3, 2008
Results First Received:	May 3, 2011
Last Updated:	October 31, 2011
Health Authority:	United States: Food and Drug Administration

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