Table of Contents
- Trial overview
- Who was studied
- Trial phases and study designs
- Outcomes and endpoints
- What the trials mean for patients
Trial overview
The trial data for Lutropin Alfa include three interventional studies, with one completed study and two authorised studies.[1][2][3] These studies were done in different patient groups and looked at hormone response and fertility-related results.[1][2][3]
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.[1] This study enrolled only 1 participant, so it was a very small clinical investigation.[1]
Another study included patients admitted to an IVF/ICSI cycle, with reasons such as tubal factor, male factor, or idiopathic infertility.[2] Idiopathic infertility means infertility with no clear cause found.[2]
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.[3] This group is described in the trial as the POSEIDON group 2 population.[3]
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.[1] It compared the response to recombinant LH with urinary hCG in men with hypogonadotropic hypogonadism.[1]
The authorised fertility study in IVF/ICSI patients was a Phase 2 multicentric randomized trial.[2] It tested whether pre-treatment with recombinant LH could improve ovarian reserve before fertility treatment.[2]
The third study was a Phase 3 randomized controlled trial in women with low ovarian sensitivity.[3] It compared treatment with rhFSH plus rhLH against rhFSH alone in a GnRH antagonist protocol.[3] A GnRH antagonist protocol is a fertility treatment plan that uses medicines to control the timing of ovulation.[3]
Outcomes and endpoints
In the Phase 4 study, the main outcome was total testosterone serum levels.[1] The study aimed to assess the pharmacodynamics of recombinant LH, meaning how the body responds to it over time.[1]
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.[2] AMH is a hormone marker often used to estimate ovarian reserve, which means the remaining egg supply.[2]
In the Phase 3 trial, the main efficacy endpoint was serum progesterone and the P4/E2 ratio on the day of ovulation triggering.[3] These measures were used to compare how the two treatment groups responded during fertility treatment.[3]
What the trials mean for patients
These trials show that Lutropin Alfa has been studied in both men and women, but for different goals.[1][2][3] In men, the focus was on hormone response, especially testosterone.[1] In women, the focus was on fertility treatment outcomes such as ovarian reserve and hormone changes during stimulation.[2][3]
The trial sizes were very different, from 1 participant in the male hormone study to 84 and 120 participants in the fertility studies.[1][2][3] This suggests that the evidence base includes both a very small exploratory study and larger randomized fertility trials.[1][2][3]
