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AzTrials

FertilityPhase 1NCT07269327

An Ethno-bridging Study of Pergoveris in Healthy Premenopausal Participants of Japanese or Caucasian Origin

A Phase 1 study testing Desogestrel and ethinylestradiol fixed dose combination and Follitropin alfa/lutropin alfa in people with Fertility, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) (r-hLH) following a single subcutaneous injection of Pergoveris in pituitary-suppressed healthy female participants of… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fertility
What is being tested?
Desogestrel and ethinylestradiol fixed dose combination and Follitropin alfa/lutropin alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited Kingdom
Study dates
24 Nov 2025to 9 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Fortrea Clinical Research Unit Ltd

    Leeds

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open Label, Single Dose, Parallel-group Study to Investigate the Pharmacokinetics of the Fixed Combination of 900 IU r-hFSH and 450 IU r-hLH Given as Pergoveris®, Administered Subcutaneously in Pituitary-suppressed Healthy Premenopausal Female Participants of Japanese or Caucasian Origin

The purpose of this study is to assess the Pharmacokinetic (PK) of Recombinant human follicle-stimulating hormone (follitropin alfa) (r-hFSH) and Recombinant human luteinizing hormone (lutropin alfa) (r-hLH) following a single subcutaneous injection of Pergoveris in pituitary-suppressed healthy female participants of Japanese or Caucasian origin. Study details include:

Study Duration: Approximately 9 weeks Treatment Duration: Approximately 4 weeks downregulation with Marvelon® and a single dose of Pergoveris.

Visit Frequency: Once in the Screening period, twice in the Downregulation period, and 8 continuous days in the study site during the Confinement period.

Conditions
Fertility
Being tested
Desogestrel and ethinylestradiol fixed dose combination, Follitropin alfa/lutropin alfa
Keywords
Clinical pharmacology, gonadotropins, infertility, prefilled pen, ethnicity
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desogestrel and ethinylestradiol fixed dose combinationDrug

    Also called Marvelon

    Participants will self-administer one tablet of desogestrel and ethinylestradiol fixed dose combination once daily to ensure downregulation.

  • Follitropin alfa/lutropin alfaCombination product

    Also called Pergoveris

    Participants will receive a combination product of follitropin alfa and lutropin alfa subcutaneously (SC) on Day 1 after confirmation of down regulation.

Study groups in NCT07269327
Study groupRoleWhat they receive
Group 1: Japanese Female ParticipantsExperimentalNot described
Receives: Drug: Desogestrel and ethinylestradiol fixed dose combination; Combination Product: Follitropin alfa/lutropin alfa
Group 2: Caucasian Female ParticipantsExperimentalNot described
Receives: Drug: Desogestrel and ethinylestradiol fixed dose combination; Combination Product: Follitropin alfa/lutropin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 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

  2. Baseline- Adjusted Maximum Observed Serum Concentration (Cmax,adj), for both r-hFSH and r-hLH

    Measured: 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 outcomes (7)

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

    Measured: From Screening to End of Study (approximately 9 weeks)

  2. Number of Participants with Clinically Significant Change From Baseline in Laboratory Parameters

    The laboratory assessment includes biochemistry, coagulation, hematology, hormonal, urinalysis parameters.

    Measured: Baseline (Day -1) upto end of study (approximately 9 weeks)

  3. Number of Participants With Abnormal Vital Signs

    Vital signs included body temperature, systolic and diastolic blood pressure, respiratory rate and pulse rate and electrocardiogram (ECG) measurements.

    Measured: Up to end of study (Approximately 9 Weeks)

  4. Participants Serum Estradiol (E2) levels

    Measured: Screening (Day -53 to Day -24) and Day-1

  5. Number of Participants With Abnormal Follicle Size and Number measured by Transvaginal Ultrasound (TVUS)

    Measured: Day-2 to Day-1 (Downregulation), and Day 6 to Day 8

  6. Number of Participants Experiencing Local Reactions

    Pain, redness, swelling, bruising, and itching around the injection site will be assessed.

    Measured: Baseline up to end of study (approximately 9 weeks)

  7. Serum Concentration of Baseline- Adjusted r-hFSH and r-hLH

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start24 Nov 2025
  3. Primary completion9 Mar 2026
  4. Study completion9 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269327
Sponsor's protocol ID
MS132705_0006
Other IDs
1012476
Status last verified
Mar 2026
First submitted
17 Nov 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Desogestrel and ethinylestradiol fixed dose combination and Follitropin alfa/lutropin alfa in people with Fertility, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07269327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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