Trial Outcomes & Findings for Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj. (NCT NCT02458768)

NCT ID: NCT02458768

Last Updated: 2016-02-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 112 participants
• Primary outcome timeframe: 36 hrs (±3 hrs) after administration of the ovulation stimulant
• Results posted on: 2016-02-03

Participant Flow

Participant milestones

Measure	IVF-M HP Inj. Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). IVF-M HP Inj.	Menopur® Inj. Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Menopur® Inj.
Overall Study STARTED	57	55
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.

Baseline characteristics by cohort

Measure	IVF-M HP Inj. n=44 Participants Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). IVF-M HP Inj.	Menopur® Inj. n=41 Participants Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Menopur® Inj.	Total n=85 Participants Total of all reporting groups
Age, Continuous	33.05 years STANDARD_DEVIATION 3.09 • n=5 Participants	33.39 years STANDARD_DEVIATION 3.19 • n=7 Participants	33.21 years STANDARD_DEVIATION 3.12 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	41 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 hrs (±3 hrs) after administration of the ovulation stimulant

Population: Per-Protocol Set

Outcome measures

Measure	IVF-M HP Inj. n=44 Participants Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). IVF-M HP Inj.	Menopur® Inj. n=41 Participants Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Menopur® Inj.
Number of Retrieved Oocytes	13.14 Oocytes Standard Deviation 7.62	10.29 Oocytes Standard Deviation 6.65

Adverse Events

IVF-M HP Inj.

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Menopur® Inj.

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	IVF-M HP Inj. n=57 participants at risk Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). IVF-M HP Inj.	Menopur® Inj. n=54 participants at risk Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Menopur® Inj.
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.00% 0/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	1.9% 1/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.

Other adverse events

Measure	IVF-M HP Inj. n=57 participants at risk Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). IVF-M HP Inj.	Menopur® Inj. n=54 participants at risk Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection. Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results). Menopur® Inj.
Gastrointestinal disorders Abdominal distension	3.5% 2/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	11.1% 6/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Nervous system disorders Dizziness	5.3% 3/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	1.9% 1/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Nervous system disorders Headache	10.5% 6/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	9.3% 5/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Gastrointestinal disorders Abdominal discomfort	5.3% 3/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	7.4% 4/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Gastrointestinal disorders Abdominal pain	7.0% 4/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	14.8% 8/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Gastrointestinal disorders Nausea	1.8% 1/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	7.4% 4/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
General disorders Lethargy	5.3% 3/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	0.00% 0/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.
Reproductive system and breast disorders Vaginal haemorrhage	1.8% 1/57 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.	5.6% 3/54 Among the 112 subjects randomized in this clinical study, one subject did not receive Investigational Product in the Menopur® Inj. group. This subject did not included in the Safety set. So total 111 subjects were included in the Safety set.

Additional Information

Jonghee Jin

LG Life Sciences

Phone: 82-2-6924-3122

Email: jonghee@lgls.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place