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Test: Follitropin alfa · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Participants will receive Test follitropin alfa in Period 1 followed by Reference follitropin alfa in Period 2. |
| Sequence 2 | EXPERIMENTAL | Participants will receive reference follitropin alfa in Period 1 followed by test follitropin alfa in Period 2. |
| Name | Type | Description |
|---|---|---|
| Test: Follitropin alfa | COMBINATION_PRODUCT | It is a solution for injection in prefilled pen. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of at least 23 days will be maintained between period 1 and 2. |
| Reference: Follitropin alfa | DRUG | It is a powder and diluent for solution for injection in multidose vial. Participants will receive follitropin alfa on Day 1 in Study Period 1 or Study Period 2. A washout period of 23 days will be maintained between period 1 and 2. |
| Zoladex | DRUG | It is a auxiliary medicinal product. Participants will receive Zoladex injection on Day -11 in down regulation period, and on Day 17 prior to the start of Period 2. |
Inclusion Criteria: * Are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring * Have a normal baseline testosterone level * Have a body weight of more than equal to 60 kilograms and Body Mass Index within th...
Follitropin alfa/lutropin alfa is used for hypogonadism and fertility. It is being developed by Merck KGaA and is currently in Phase 1 clinical development. The drug is a small molecule therapeutic being studied in healthy volunteers to assess bioequivalence and ethno-bridging effects.
Follitropin alfa/lutropin alfa is being developed by Merck KGaA, a company traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development for hypogonadism and fertility indications.
Follitropin alfa/lutropin alfa is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one with 55 participants and another with 24 participants.
Follitropin alfa/lutropin alfa has completed two Phase 1 trials. NCT07097259 assessed bioequivalence of follitropin alfa solution in pen versus powder in vial in healthy downregulated male participants with hypogonadism. NCT07269327 was an ethno-bridging study in healthy premenopausal Japanese or Caucasian participants for fertility.
Follitropin alfa/lutropin alfa is associated with the product name Pergoveris. One of its clinical trials, NCT07269327, is titled 'An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin,' indicating that Pergoveris is a brand name for this combination.