In short
Clinical trials investigating Lutropin Alfa are studying how it performs in different patient groups, including men with hypogonadotropic hypogonadism and women in IVF/ICSI fertility treatment. These studies look at safety, hormone response, and fertility-related outcomes in phase 2, 3, and 4 research.
Key points
- Clinical trials of Lutropin Alfa are focused on hormone response and fertility treatment. One Phase 4 study looked at hypogonadotropic hypogonadal men and measured total testosterone. A Phase 2 trial studied women in IVF/ICSI cycles and looked at whether pre-treatment could improve ovarian reserve, using basal AMH as the main endpoint. A Phase 3 randomized trial studied women over 35 with low ovarian sensitivity and compared treatment groups using serum progesterone and the P4/E2 ratio on the day of ovulation triggering. Overall, the trials cover both male and female populations and focus on endocrine and fertility-related outcomes.
Trial overview
The trial data for Lutropin Alfa include three interventional studies, with one completed study and two authorised studies. These studies were done in different patient groups and looked at hormone response and fertility-related results.
Who was studied
One study included men with hypogonadotropic hypogonadism, a condition where the body does not send enough signals to support normal sex hormone production. This study enrolled only 1 participant, so it was a very small clinical investigation.
Another study included patients admitted to an IVF/ICSI cycle, with reasons such as tubal factor, male factor, or idiopathic infertility. Idiopathic infertility means infertility with no clear cause found.
The third study focused on women older than 35 years with low ovarian sensitivity, who had shown a previous suboptimal response in an earlier cycle. This group is described in the trial as the POSEIDON group 2 population.
Trial phases and study designs
The completed study was a Phase 4 interventional trial, which means it was a later-stage study done in a clinical setting. It compared the response to recombinant LH with urinary hCG in men with hypogonadotropic hypogonadism.
The authorised fertility study in IVF/ICSI patients was a Phase 2 multicentric randomized trial. It tested whether pre-treatment with recombinant LH could improve ovarian reserve before fertility treatment.
The third study was a Phase 3 randomized controlled trial in women with low ovarian sensitivity. It compared treatment with rhFSH plus rhLH against rhFSH alone in a GnRH antagonist protocol. A GnRH antagonist protocol is a fertility treatment plan that uses medicines to control the timing of ovulation.
Outcomes and endpoints
In the Phase 4 study, the main outcome was total testosterone serum levels. The study aimed to assess the pharmacodynamics of recombinant LH, meaning how the body responds to it over time.
In the Phase 2 study, the primary endpoint was to see whether pre-treatment with rhLH at 187.5 IU/day for 60 days could improve ovarian reserve, as shown by an increase in basal AMH. AMH is a hormone marker often used to estimate ovarian reserve, which means the remaining egg supply.
In the Phase 3 trial, the main efficacy endpoint was serum progesterone and the P4/E2 ratio on the day of ovulation triggering. These measures were used to compare how the two treatment groups responded during fertility treatment.
What the trials mean for patients
These trials show that Lutropin Alfa has been studied in both men and women, but for different goals. In men, the focus was on hormone response, especially testosterone. In women, the focus was on fertility treatment outcomes such as ovarian reserve and hormone changes during stimulation.
The trial sizes were very different, from 1 participant in the male hormone study to 84 and 120 participants in the fertility studies. This suggests that the evidence base includes both a very small exploratory study and larger randomized fertility trials.