Trial · NCT01084265
A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
NCT01084265, Phase 3, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2012-05-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism. Trials, record NCT01084265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01084265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Using Recombinant Human Luteinizing Hormone (r-hLH, Luveris®) in the Treatment of Chinese Women With Hypogonadotropic Hypogonadism
- NCT number
- NCT01084265
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Hypogonadism
- Interventions
- Recombinant human luteinizing hormone (r-hLH), Recombinant human follicle-stimulating hormone (r-hFSH), Human chorionic gonadotropin (hCG)
- First posted
- 2010-03-10
- Last updated
- 2013-12-27
- Results first posted
- 2012-05-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Met Both Index 1 and Index 2 | 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. |
| Primary | Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter | Day 14 | |
| Primary | Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection | Day 14 | |
| Primary | Number of Participants Who Refused to Take hCG Injection | Day 14 | Participant refused to take hCG injection for the concern of OHSS or the participant was pregnant. |
| Secondary | Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle | Day 14 | |
| Secondary | Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle | Day 14 | |
| Secondary | Average Change of E2 Level in Participants Per Day up to Day 14 | 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 \[hCG administration day\]). |
| Secondary | Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Met Both Index 1 and Index 2 | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | participants | NUMBER |
| PRIMARY | Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | participants | NUMBER |
| PRIMARY | Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | participants | NUMBER |
| PRIMARY | Number of Participants Who Refused to Take hCG Injection | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | participants | NUMBER |
| SECONDARY | Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | follicles | MEAN |
| SECONDARY | Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | follicles | MEAN |
| SECONDARY | Average Change of E2 Level in Participants Per Day up to Day 14 | up to Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | pg/mL per day | MEAN |
| SECONDARY | Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Day 14 | Per protocol set included all participants who completely met all the requirements of clinical trial protocol. | participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 14 | Safety analysis set included all participants who received investigational drug for at least one time. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Met Both Index 1 and Index 2 | Recombinant Human Luteinizing Hormone (Luveris) | 23 | participants | ||
| Number of Participants Who Had at Least One Follicle Greater Than 17mm in Diameter | Recombinant Human Luteinizing Hormone (Luveris) | 23 | participants | ||
| Number of Participants With E2 Level in Blood Serum Above 109 pg/mL on the Day of hCG Injection | Recombinant Human Luteinizing Hormone (Luveris) | 23 | participants | ||
| Number of Participants Who Refused to Take hCG Injection | Recombinant Human Luteinizing Hormone (Luveris) | Refused due to concern of OHSS | 0 | participants | |
| Number of Participants Who Refused to Take hCG Injection | Recombinant Human Luteinizing Hormone (Luveris) | Refused due to pregnancy | 10 | participants | |
| Mean Number of Follicles With Diameter in the Range of 10-17 mm on the Day of hCG Injection in Treatment Cycle | Recombinant Human Luteinizing Hormone (Luveris) | 3.57 | Standard Deviation 4.07 | follicles | |
| Mean Number of Follicles With the Diameter Above 17 mm on the Day of hCG Injection in Treatment Cycle | Recombinant Human Luteinizing Hormone (Luveris) | 2.13 | Standard Deviation 2.00 | follicles | |
| Average Change of E2 Level in Participants Per Day up to Day 14 | Recombinant Human Luteinizing Hormone (Luveris) | 71.03 | Standard Deviation 64.53 | pg/mL per day | |
| Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Recombinant Human Luteinizing Hormone (Luveris) | Biochemical Pregnancies | 1 | participants | |
| Number of Participants With Confirmed Pregnancies: Biochemical Pregnancies and Clinical Pregnancies | Recombinant Human Luteinizing Hormone (Luveris) | Clinical Pregnancies | 9 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Recombinant Human Luteinizing Hormone (Luveris) | 31 | |
| Overall Study | COMPLETED | Recombinant Human Luteinizing Hormone (Luveris) | 31 | |
| Overall Study | NOT COMPLETED | Recombinant Human Luteinizing Hormone (Luveris) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Recombinant Human Luteinizing Hormone (Luveris) | ||
| Total, other adverse events | Recombinant Human Luteinizing Hormone (Luveris) | 0 | 31 |
| Total, serious adverse events | Recombinant Human Luteinizing Hormone (Luveris) | 0 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01084265
GET https://conductscience.org/api/trials/v1/NCT01084265/registered