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Follitropin alfa/lutropin alfa

Phase 1

Fertility | Small molecule | Other |Merck KGaA|Last Updated: Mar 18, 2026

Success Probability

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Follitropin alfa/lutropin alfa · 1 trial · 1 indication

Phase 1 1
NCT07269327An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian OriginFertility
COMPLETED24 Analytics
PHASE1COMPLETED
An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin
Fertility
NCT0726932724
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Study Endpoints

Primary Endpoints

Baseline-Adjusted Area Under the Serum Concentration- Time Curve from Time Zero to Last Quantifiable Sampling Time After Administration (AUC0-tlast,adj) for both r-hFSH and r-hLH
Predose (baseline), 2 hour(hr), 4, 6, 7, 8, 9, 10, 12,15 and 18hr post-dose on Day 1; 24hr, 36hr post-dose on Day 2; 48hr post-dose on Day 3; 72 hr post dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6 and 168hr post-dose on Day 8
Baseline- Adjusted Maximum Observed Serum Concentration (Cmax,adj), for both r-hFSH and r-hLH
Predose (baseline), 2 hour(hr), 4, 6, 7, 8, 9, 10, 12,15 and 18hr post-dose on Day 1; 24hr, 36hr post-dose on Day 2; 48hr post-dose on Day 3; 72 hr post dose on Day 4; 96hr post-dose on Day 5; 120hr post-dose on Day 6 and 168hr post-dose on Day 8

Secondary Endpoints

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
From Screening to End of Study (approximately 9 weeks)
Number of Participants with Clinically Significant Change From Baseline in Laboratory Parameters
Baseline (Day -1) upto end of study (approximately 9 weeks)
Number of Participants With Abnormal Vital Signs
Up to end of study (Approximately 9 Weeks)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1: Japanese Female ParticipantsEXPERIMENTAL -
Group 2: Caucasian Female ParticipantsEXPERIMENTAL -

Interventions

NameTypeDescription
Desogestrel and ethinylestradiol fixed dose combinationDRUGParticipants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.
Follitropin alfa/lutropin alfaCOMBINATION_PRODUCTParticipants will receive a combination product of follitropin alfa and lutropin alfa subcutaneously (SC) on Day 1 after confirmation of down regulation.
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participant who are overtly healthy, as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring * Participant who have a negative urine pregnancy test before starting Marvelon and on the day before the Pergove...

Countries:United Kingdom
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Frequently asked questions about Follitropin alfa/lutropin alfa

What is Follitropin alfa/lutropin alfa used for?

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.

Who makes Follitropin alfa/lutropin alfa?

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.

What phase is Follitropin alfa/lutropin alfa in?

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.

What clinical trials is Follitropin alfa/lutropin alfa in?

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.

Is Follitropin alfa/lutropin alfa the same as Pergoveris?

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.