Primary outcomeNumber· Day 14
Number of Participants Who Met Both Index 1 and Index 2
| Group | Value (participants) |
|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 23 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
NCTNCT01084265 (opens ClinicalTrials.gov in a new tab)Other idIMP25345
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 31 participants (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
China
- Start
- Feb 2004
- Primary completion
- Dec 2005
- Completion
- Dec 2005
- First posted
- 10 Mar 2010 (estimated)
- Last update posted
- 27 Dec 2013 (estimated)
- Conditions
- Hypogonadism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200420052006
- Ph 3
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
NCT01084265Feb 2004 to Dec 2005
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.
Interventions
- Recombinant human luteinizing hormone (r-hLH)Drug
- Recombinant human follicle-stimulating hormone (r-hFSH)Drug
- Human chorionic gonadotropin (hCG)Drug
Arms0
The registry lists no arms for this trial.
Primary outcomes4
Outcomes the sponsor listed as primary.
Number of Participants Who Met Both Index 1 and Index 2
Time frame · Day 14
Registry description
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
Registry description
Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant.
Secondary outcomes(5)
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
Registry description
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
Registry description
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
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeNumber· Day 14
Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter
| Group | Value (participants) |
|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 23 |
Primary outcomeNumber· Day 14
Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection
| Group | Value (participants) |
|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 23 |
Primary outcomeNumber· Day 14
Number of Participants Who Refused to Take hCG Injection
| Group | Value (participants) |
|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 0 |
Secondary and other outcome results(4)
Secondary outcomeMean· Day 14
Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle
| Group | Value (follicles) | Spread |
|---|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 3.57 | 4.07 |
Secondary outcomeMean· Day 14
Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle
| Group | Value (follicles) | Spread |
|---|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 2.13 | 2.00 |
Secondary outcomeMean· up to Day 14
Average Change of E2 Level in Participants Per Day up to Day 14
| Group | Value (pg/mL per day) | Spread |
|---|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 71.03 | 64.53 |
Secondary outcomeNumber· Day 14
Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies
| Group | Value (participants) |
|---|---|
| Recombinant Human Luteinizing Hormone (Luveris) | 1 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 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 \[mm\]). | – | 0 / 31 | 0 / 31 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Be premenopausal, between 18 and 39 years of age
* Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism during screening procedure
* Have discontinued gonadotropins, gonadotropin-releasing hormone (GnRH) (gonadotropin naïve), or estrogen progesterone replacement therapy at least one month before the screening procedure
* Have a negative progestin challenge test performed during screening
* Have the following hormonal values in a centrally analyzed fasting blood sample, drawn within 6 months before initiation of treatment:
* Follicular stimulating hormone (FSH): \< 5 international units/liter (IU/L)
* Luteinizing hormone (LH): \< 1.2 IU/L
* Oestradiol (E2): \< 60 picogram/milliliter (pg/mL) (\<220 picomolar/liter \[pmol/L\])
* Prolactin (PRL): \< 44.3 nanogram/milliliter (ng/mL) (\< 1040 milli-international units/liter \[mIU/L\])
* Thyrotrophin-stimulating hormone (TSH): \< 6.5 micro-international units (uIU/mL)
* Free Thyroxine (T4): 0.8-1.8 nanogram/deciliter (ng/dL) (11-24 pmol/L)
* Triiodothyronine (T3): \< 1.0 ng/mL (\< 3.5 nanomolar/liter \[nmol/L\])
* Have an endovaginal pelvic ultrasound scan showing (i) no ovarian tumor and cyst \< 2 centimeters (cm); (ii) no clinically significant uterine abnormality, and (iii) \< 13 mm small follicles (mean diameter \< 10 mm) on the largest section through each ovary
* Have a normal cervical pap smear within 6 months of the initial visit
* Have a body mass index (BMI) between 18.4 and 31.4 kilogram/meter square (kg/m\^2)
* Be willing and able to comply with the protocol for the duration of the study
* Have given written informed consent prior to any study related procedure
Exclusion Criteria:
* Ongoing pregnancy
* Any chronic systemic disease
* Hypersensitive to study drug and control drug
* History of severe ovarian hyperstimulation syndrome
* Abnormal gynecological bleeding of undetermined origin
* Previous or current hormone dependent tumor
* Known active substance abuse or eating disorder
* Known central nervous system (CNS) lesions: In cases where hypogonadotropic hypogonadism (HH) is secondary to a CNS lesion or its treatment, the subject will not be eligible without consulting Serono's Medical Director
* Exercise program exceeding 10 hours per week
* Currently undergoing treatment with psychotropic medication or with any other medication known to interfere with normal reproductive function (for example, neuroleptics, dopamine antagonists)
* There is any abnormality, decided by investigators, which might produce effect on the absorption, distribution and excretion of investigational drug
PepBank is a research reference. Talk to a doctor before you use any peptide.