Time to Clinical Pregnancy
| Group | Value (Days) |
|---|---|
| Luveris® 75 IU | 71 |
| Luveris® 25 IU | 51 |
| Placebo | 103 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Please see "Purpose" statement
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])
NCT00328926Mar 2006 to May 2012
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
Active comparator
Luveris® 75 IU
Active comparator
Luveris® 25 IU
Placebo comparator
Placebo
Outcomes the sponsor listed as primary.
Time to Clinical Pregnancy
Time frame · Stimulation Day 1 up to clinical pregnancy (Day 35-42 post r-hCG administration day [end of stimulation cycle {approximately 21 days}])
Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination.
Percentage of Participants With Cumulative Clinical Pregnancy
Time frame · Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days])
Clinical pregnancy was defined as the presence of one or more fetal sac with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. Cumulative clinical pregnancy referred to all clinical pregnancy that occurred during all the 3 treatment cycles.
Percentage of Participants With Cumulative Ovulation
Time frame · Recombinant human chorionic gonadotropin (r-hCG) administration day (end of stimulation cycle [approximately 21 days])
Ovulation was defined as a mid-luteal phase progesterone (P4) level greater than or equal to (\>=) 10 nanogram per milliliter (ng/mL). Cumulative ovulation referred to all ovulations that occurred during all the 3 treatment cycles.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Days) |
|---|---|
| Luveris® 75 IU | 71 |
| Luveris® 25 IU | 51 |
| Placebo | 103 |
| Group | Value (Percentage of participants) |
|---|---|
| Luveris® 75 IU | 60.0 |
| Luveris® 25 IU | 33.3 |
| Placebo | 33.3 |
| Group | Value (Percentage of participants) |
|---|---|
| Luveris® 75 IU | 80.0 |
| Luveris® 25 IU | 33.3 |
| Placebo | 66.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Luveris® 75 IURecombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. | – | 1 / 5 | 4 / 5 |
| Luveris® 25 IURecombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. | – | 0 / 3 | 1 / 3 |
| PlaceboPlacebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles. | – | 1 / 3 | 3 / 3 |
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