CompletedPhase 1

Pharmacokinetics of FSH and hCG After a Single Subcutaneous Injection of Gonadotropins-IBSA

Canada29 participantsStarted 2024-09-15

Plain-language summary

The objectives of this study is to evaluate the PK and the dose-proportionality of FSH and HCG following a single dose of Gonadotropins-IBSA, administered subcutaneously.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 72.
✓. Females who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for atleast 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

Exclusion criteria

✕. 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.
✕. 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%).

What they're measuring

Primary PK endpoints FSH

Timeframe: until 240 hours post dose

Primary PK endpoints hCG

Timeframe: until 240 hours post dose.

Dose-proportionality of FSH

Timeframe: until 240 hours post dose

Dose-proportionality of FSH

Timeframe: until 240 hours post dose

Dose-proportionality of hCG

Timeframe: until 240h post dose

Dose-proportionality of hCG

Timeframe: until 240h post dose

Trial details

NCT IDNCT06781957

SponsorIBSA Institut Biochimique SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-13

View on ClinicalTrials.gov More OVARIAN STIMULATION trials

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 72.
✓. Females who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomized for atleast 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

Exclusion criteria

✕. 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.
✕. 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%).

What they're measuring

Primary PK endpoints FSH

Timeframe: until 240 hours post dose

Primary PK endpoints hCG

Timeframe: until 240 hours post dose.

Dose-proportionality of FSH

Timeframe: until 240 hours post dose

Dose-proportionality of FSH

Timeframe: until 240 hours post dose

Dose-proportionality of hCG

Timeframe: until 240h post dose

Dose-proportionality of hCG

Timeframe: until 240h post dose