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Fertility drug pergoveris tested in japanese and caucasian women

NCT ID NCT07269327

Knowledge-focused Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed phase 1 study looked at how the fertility drug Pergoveris (a combination of two hormones, FSH and LH) is processed in the body of 24 healthy premenopausal women of Japanese or Caucasian origin. Participants took a birth control pill for about 4 weeks to suppress their natural hormones, then received a single injection of Pergoveris. The goal was to measure hormone levels in the blood and check for side effects, helping to guide future dosing in fertility treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pergoveris (follitropin alfa and lutropin alfa)
What this could lead to
If successful, this study could help doctors choose the right dose of Pergoveris for fertility treatments in women of different ethnic backgrounds.
What could go wrong
This is a very early, small study (24 healthy women) looking at drug levels, not actual fertility outcomes. Results may not apply to women with fertility issues or other ethnic groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Nov 2025

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 Pergoveris dose (Day -1) * Participant who have a normal baseline FSH (\< 12 IU/L) and E2 levels less than or equal (\<=) 100 picogram per mililiter (pg/mL) and follicles \<= 11 millimeter (mm) in diameter at Screening * Participant who have a normal ThinPrep® cytologic test (TCT) during Screening * Other protocol defined inclusion criteria may apply Exclusion Criteria: * Participant with any condition that, in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation * Participants with any clinically significant abnormalities of the genital organs as determined by gynecological examination and transvaginal ultrasound scan (TVUS) and based on the Investigator's judgment (e.g. ovarian tumors, nonfunctional ovarian cysts, and endometrial hyperplasia) * Participant with imminent planned major surgery * Participant with a History of tumors of the pituitary gland or hypothalamus * Other protocol defined exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fertility

Contacts and locations

Locations

  • Fortrea Clinical Research Unit Ltd

    Leeds, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.