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Follitropin alfa liquid formulation · 1 trial · 2 indications
Convenience parameters included nurse/subjects preference; time to train subject; operative tolerance and wastage of product which were assessed during the post-treatment period. Safety parameters included local reactions (pain, bruising, redness, itching, swelling)and adverse drug events which were assessed during the pre-treatment, treatment and post-treatment period.
| Arm | Type | Description |
|---|---|---|
| Gonal-f | EXPERIMENTAL | - |
| Puregon | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Follitropin alfa liquid formulation | DRUG | Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center |
| Follitropin beta liquid formulation | DRUG | Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center |
Inclusion Criteria: * Pre-menopausal woman, between her 18th and 39th birthday, receiving recombinant FSH as stimulation for IVF and/or ICSI * Subjects who were able to communicate well with the investigator and to comply with the requirements of the entire study * Subjects who had given written in...
Follitropin alfa liquid formulation is used for infertility and ovulation induction. It is a small molecule being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development. The drug is intended to help women who are undergoing fertility treatment.
Follitropin alfa liquid formulation is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy for infertility and ovulation induction.
Follitropin alfa liquid formulation is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to inform further development.
Follitropin alfa liquid formulation has one completed Phase 3 trial, NCT01081639, which evaluated the convenience, safety, and efficacy of the drug compared with Follitropin beta liquid pen. The trial enrolled 34 female participants aged 18 years and older with infertility.
Follitropin alfa liquid formulation is not the same as Follitropin beta. The Phase 3 trial NCT01081639 compared Follitropin alfa liquid formulation with Follitropin beta liquid pen as an active control, indicating they are distinct drug products.