A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
|ClinicalTrials.gov Identifier: NCT01084265|
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : May 22, 2012
Last Update Posted : December 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Hypogonadism||Drug: Recombinant human luteinizing hormone (r-hLH) Drug: Recombinant human follicle-stimulating hormone (r-hFSH) Drug: Human chorionic gonadotropin (hCG)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial on Application of Injectable Recombinant Human Luteinizing Hormone (Luveris®) in the Treatment of Chinese Female Patients With Hypogonadotropic Hypogonadism: A Multi-center, Open, Prospective Drug Clinical Trial for Registration|
|Study Start Date :||February 2004|
|Primary Completion Date :||December 2005|
|Study Completion Date :||December 2005|
Drug: Recombinant human luteinizing hormone (r-hLH)
- Number of Participants Who Met Both Index 1 and Index 2 [ Time Frame: Day 14 ]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.
- Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter [ Time Frame: Day 14 ]
- Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection [ Time Frame: Day 14 ]
- Number of Participants Who Refused to Take hCG Injection [ Time Frame: Day 14 ]Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.
- Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle [ Time Frame: Day 14 ]
- Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle [ Time Frame: Day 14 ]
- Average Change of E2 Level in Participants Per Day up to Day 14 [ Time Frame: up to Day 14 ]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]).
- Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies [ Time Frame: Day 14 ]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.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 14 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084265
|Peking Union Medical College Hospital|
|Beijing, China, 100730|
|Study Director:||Xin Li||Merck Pte. Ltd., Singapore|