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Ovarian StimulationPhase 1NCT06659692

Pharmacokinetics of FSH and hCG Following Multiple Dose of Gonadotropins-IBSA.

A Phase 1 study testing Gonadotropins Subcutaneous in people with Ovarian Stimulation and Infertility, run by IBSA Institut Biochimique SA at 2 sites in Canada.

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

Pharmacokinetics of FSH and hCG after multiple subcutaneous injection of Gonadotropins-IBSA. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Stimulation, Infertility
What is being tested?
Gonadotropins Subcutaneous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesCanada
Study dates
23 Sep 2024to 29 Aug 2025
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female of childbearing potential, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤45 years of age, with BMI \>18.5 and \<32.0 kg/m2 and body weight ≥45.0 kg.
  • Healthy as defined by:
  • the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
  • the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
  • Use of a COC containing at least 20 µg of ethinyl estradiol for at least 3 months prior to screening and willing to keep using the same oral contraceptive until the end of the study. The usual regimen (with hormone-free interval or continuous dosing) will be allowed until Day -1. Subjects must agree to take the COC in a continuous manner (no hormone-free interval) from Day 1 to Day 36.
  • Females who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for at least 3 months prior to dosing) must be willing to use a male condom with intravaginally applied spermicide or total abstinence from heterosexual intercourse (when this is in line with the preferred and usual lifestyle of the subject) from screening and throughout the study and for 30 days after the last study drug administration.
  • Able to understand the study procedures and provide signed informed consent to participate in the study

Who cannot join

  • Any clinically significant abnormal finding at physical examination at screening.
  • Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
  • Positive pregnancy test or lactating subject.
  • Positive urine drug screen, urine cotinine test, or alcohol breath test.
  • Known allergic reactions to FSH, hCG, other gonadotropins, or other related drugs, or to any excipient in the formulation.
  • Clinically significant ECG abnormalities or vital signs abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
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  • History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.
  • History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 10 units of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
  • FSH levels > 4 IU/L at admission in each period.
  • Presence of ovarian cysts > 10 mm in size or clinically significant ovarian enlargement at admission (Day 19).
  • Clinically significant history of an abnormal menstrual cycle.
  • Abnormal Pap smear prior to administration of the study drug (result is valid for 12 months).
  • History of ovarian cysts or enlargement.
  • History or presence of polycystic ovary syndrome.
  • Presence of undiagnosed vaginal and/or urinary tract bleeding.
  • History or presence of sex hormone dependent tumours of reproductive tract and accessory organs.
  • History of hypothalamus or pituitary gland tumours.
  • Personal history or strong family history (first degree relative) of coagulation disorders such as thromboembolic diseases (e.g., thrombophlebitis, pulmonary embolism or coagulation factors deficiency).
  • History of rare hereditary galactose and/or lactose intolerance (e.g., congenital lactase deficiency [CLD] or glucose-galactose malabsorption [GGM]).
  • Tattoos covering the potential study drug injection site or any skin conditions that would prevent the injection (e.g., psoriasis, major scar, etc.).
  • Use of medications for the timeframes specified below, except for the subject's prescribed COC and medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
  • depot injection or implant of any drug within 3 months prior to study drug administration;
  • prescription medications within 14 days prior to study drug administration;
  • any vaccines, including COVID-19 vaccine, within 14 days prior to study drug administration;
  • over-the-counter (OTC) products and natural health products (including herbal remedies such as St. John's wort, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to study drug administration, with the exception of the occasional use of acetaminophen (up to 2 g daily);
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
  • Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to dosing.
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Syneos Health

    Québec, Quebec, GIP 0A2

  • Pharma Medica Research Inc.

    Toronto, Ontario, M1S 3V6

Other trials in Canada

About this study

Official title: Pharmacokinetics of Follicle-stimulating Hormone and Human Chorionic Gonadotrophin Following Multiple Daily Subcutaneous Injections of Gonadotropins-IBSA in Pituitary Down-regulated Female Subjects.

Pharmacokinetics of FSH and hCG after multiple subcutaneous injection of Gonadotropins-IBSA.

Being tested
Gonadotropins Subcutaneous
Medical subject headings
Infertility

What participants receive

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

  • Gonadotropins SubcutaneousDrug

    Gonadotropins s.c. multiple dose

Study groups in NCT06659692
Study groupRoleWhat they receive
Gonadotropins 150 IUExperimental150 IU daily for 7 days.
Receives: Drug: Gonadotropins Subcutaneous
Gonadotropins 300 IUExperimental300 IU daily for 7 days
Receives: Drug: Gonadotropins Subcutaneous

What is being measured

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

  1. Primary PK endpoints

    Day 20: AUC0-24

    Measured: until 240 hours post dose.

  2. Primary PK endpoints

    Day 20:Cmax: to assess the bioavailability of the test product in terms of rate (baseline-corrected, dose-normalised Cmax) of Gonadotropins-IBSA absorption after multiple s.c. injection to healthy female subjects.

    Measured: until 240 hours post dose.

  3. Primary PK endpoints

    Day 20: Tmax (Time to achieve Cmax)

    Measured: until 240 hours post dose.

  4. Primary PK endpoints

    Day 26: AUC0-24

    Measured: until 240 hours post dose.

  5. Primary PK endpoints

    Day 26: Cmax: to assess the bioavailability of the test product in terms of rate (baseline-corrected, dose-normalised Cmax) of Gonadotropins-IBSA absorption after multiple s.c. injection to healthy female subjects.

    Measured: until 240 hours post dose.

  6. Primary PK endpoints

    Day 26: Tmax (Time to achieve Cmax)

    Measured: until 240 hours post dose.

  7. Primary PK endpoints

    Accumulation potential: Rac

    Measured: Through the duration of the study

Secondary outcomes (11)

  1. Inhibin B

    Analysis of Inhibin B

    Measured: until 240 hour post last dose

  2. Estradiol (E2)

    Analysis of Estradiol (E2)

    Measured: until 240 hour post last dose.

  3. Number of Follicle

    Follicle growth

    Measured: After seven days of treatment

  4. Adverse events (AEs)

    Percentage of subjects with any AEs

    Measured: From the signature of the Informed Consent until the end of the study.

  5. Immunogenicity

    Incidence of anti-FSH antibodies be analyzed only for subjects with ADA positive results.

    Measured: At pre-dose on Day 20.

  6. Immunogenicity

    Incidence of anti-FSH antibodies be analyzed only for subjects with ADA positive results.

    Measured: 240 hours post-last dose

  7. Immunogenicity

    Incidence of anti-FSH antibodies

    Measured: 576 hours post last dose

  8. Immunogenicity

    Incidence anti-hCG antibodies

    Measured: At pre-dose on Day 20

  9. Immunogenicity

    Incidence anti-hCG antibodies

    Measured: 240 hours post-last dose and 576 hours post last dose.

  10. Immunogenicity

    Incidence anti-hCG antibodies

    Measured: 576 hours post last dose.

  11. Immunogenicity

    Neutralizing antibodies (NAbs)

    Measured: Only for subjects with ADA positive

Timeline

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

  1. First posted26 Oct 2024
  2. Study start23 Sep 2024
  3. Primary completion29 Aug 2025
  4. Study completion29 Aug 2025

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06659692
Sponsor's protocol ID
23CDN-FCG09
Status last verified
Jul 2026
First submitted
16 Oct 2024
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gonadotropins Subcutaneous in people with Ovarian Stimulation and Infertility, run by IBSA Institut Biochimique SA at 2 sites in Canada.

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 7 inclusion and 28 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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?

Primary PK endpoints (time frame: until 240 hours post dose.). The study lists 7 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 NCT06659692.

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 16 Jul 2026.

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