Trial Outcomes & Findings for A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism (NCT NCT01084265)
NCT ID: NCT01084265
Last Updated: 2013-12-27
Results Overview
The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.
COMPLETED
PHASE3
31 participants
Day 14
2013-12-27
Participant Flow
Participant milestones
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
COMPLETED
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31
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
Baseline characteristics by cohort
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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Age, Continuous
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30.1 years
STANDARD_DEVIATION 4.09 • n=93 Participants
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Sex: Female, Male
Female
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30 Participants
n=93 Participants
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Sex: Female, Male
Male
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0 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
The three indices were defined as; Index 1: diameter of at least one follicle is greater than 17 mm; Index 2: serum oestradiol (E2) level in blood serum above 109 picogram/ milliliter (pg/mL) on human chorionic gonadotropin (hCG) injection day; Index 3: participant refuses to take hCG injection for the concern of ovarian hyperstimulation syndrome (OHSS) or participant is pregnant. A subset of these participants met Index 3.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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Number of Participants Who Met Both Index 1 and Index 2
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23 participants
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PRIMARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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|---|---|
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Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter
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23 participants
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PRIMARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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|---|---|
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Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection
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23 participants
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PRIMARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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|---|---|
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Number of Participants Who Refused to Take hCG Injection
Refused due to concern of OHSS
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0 participants
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Number of Participants Who Refused to Take hCG Injection
Refused due to pregnancy
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10 participants
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SECONDARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle
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3.57 follicles
Standard Deviation 4.07
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SECONDARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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|---|---|
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Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle
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2.13 follicles
Standard Deviation 2.00
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SECONDARY outcome
Timeframe: up to Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
The average change was calculated by assessing the E2 levels on 4 timepoints until day 14 (day 1, day 5, day 10, day 14 \[hCG administration day\]).
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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Average Change of E2 Level in Participants Per Day up to Day 14
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71.03 pg/mL per day
Standard Deviation 64.53
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SECONDARY outcome
Timeframe: Day 14Population: Per protocol set included all participants who completely met all the requirements of clinical trial protocol.
Biochemical pregnancy was defined as a pregnancy diagnosed only by the detection of hCG in serum or urine and that does not develop into a clinical pregnancy. Clinical pregnancy was defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=30 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies
Biochemical Pregnancies
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1 participants
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Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies
Clinical Pregnancies
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9 participants
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SECONDARY outcome
Timeframe: Day 14Population: Safety analysis set included all participants who received investigational drug for at least one time.
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.
Outcome measures
| Measure |
Recombinant Human Luteinizing Hormone (Luveris)
n=31 Participants
Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter \[mm\]).
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events
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0 participants
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serious Adverse Events
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0 participants
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Adverse Events
Recombinant Human Luteinizing Hormone (Luveris)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER