InfertilityPhase 1NCT03735030
Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation
A Phase 1 study testing Human hCG 10'000 IU and Recombinant hCG 6'500 IU in people with Infertility, run by IBSA Institut Biochimique SA at 1 site in Switzerland.
Trial summary
In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Human hCG 10'000 IU and Recombinant hCG 6'500 IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Nov 2018to 2 Aug 2019
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent: signed written informed consent before inclusion in the study;
- Sex and Age: healthy pre-menopausal women, 20-45 years old inclusive;
- Body Mass Index: 18.5-30 kg/m2 inclusive;
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position;
- Hormonal oral contraceptives: Combined oral contraceptive pill for at least 2 months before the screening visit;
- Menstrual cycle: history of a normal menstrual cycle before combined oral contraceptive pill use;
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- hCG: endogenous hCG levels <1.2 IU/L at screening and Day -1, Period 1;
- Pituitary down-regulation: Luteinizing hormone (LH) <5 IU/L; Follicle stimulating hormone (FSH) <4 IU/L at Day -1, Period 1;
- Papanicolaou smear (PAP) test: negative or not clinically significant PAP test results within 12 months before the screening visit or at screening;
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study;
- Additional contraception: study participants with an active sexual life must be using one additional contraceptive method, as follows:
- A male sexual partner who agrees to use a male condom with spermicide
- A sterile sexual partner.
Who cannot join
- Contraindications: any contraindications to combined oral contraceptive pill or gonadotropins;
- Electrocardiogram 12-leads (supine position): clinically significant abnormalities;
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study;
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness;
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study;
- Diseases: relevant history of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, immunological, dermatological, endocrine, genitourinary (e.g. polycystic ovary disease, ovarian cysts, primary ovarian failure, early menopause or abnormal bleeding of undetermined origin), malignant neoplasia, neurological or psychiatric diseases that could interfere with the aim of the study;
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- Medications: treatment with gonadotropin preparations within 6 months prior to screening; other medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study;
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study;
- Blood donation: blood donations for 3 months before this study;
- Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day defined according to the United Stated Department of Agriculture (USDA) Dietary Guidelines 2015-2020; 17), caffeine (>5 cups coffee/tea/day) or tobacco abuse (≥10 cigarettes/day);
- Drug test: positive result at the drug test at screening or day -1, Period 1;
- Alcohol test: positive alcohol breath test on day -1;
- Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians;
- Pregnancy: positive or missing pregnancy test at screening or at day -1 of each period; pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Bioavailability Study of Choriomon® (IBSA) Versus a Marketed hCG Formulation, Following Subcutaneous Administration in Healthy Women. Single-dose, Open-label, Randomized, Two-period, Two-way Cross-over, Bioavailability Study
In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years.
- Conditions
- Infertility
- Being tested
- Human hCG 10'000 IU, Recombinant hCG 6'500 IU
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human hCG 10'000 IUDrug
A single dose of 10'000 IU of human hCG will be injected in 24 healthy subject volunteers.
Recombinant hCG 6'500 IUDrug
A single dose of 6'500 IU recombinant hCG will be injected in 24 healthy subject volunteers.
| Study group | Role | What they receive |
|---|---|---|
| human hCG | Experimental | Not described Receives: Drug: Human hCG 10'000 IU |
| recombinant hCG | Active comparator | Not described Receives: Drug: Recombinant hCG 6'500 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of absorption (Cmax)
To assess the bioavailability of the test and reference products in terms of rate (baseline-corrected, dose-normalised Cmax) of hCG absorption after single s.c. injection to healthy female subjects.
Measured: 192 hours post dose
Extent of absorption (AUC0-t), Area under the concentration-time curve
To assess the bioavailability of the test and reference products in terms of extent (baseline-corrected, dose-normalised AUC0-t) of hCG absorption after single s.c. injection to healthy female subjects.Area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
Measured: 192 hours post dose
Secondary outcomes (5)
t1/2: Half-life
To evaluate the baseline-corrected, dose-normalised (when applicable) t1/2 (Half-life) value after single dose administration of test and reference products;
Measured: 192 hours post dose
Tmax: Time to achieve Cmax
To evaluate the baseline-corrected, dose-normalised (when applicable) Tmax value after single dose administration of test and reference products;
Measured: 192 hours post dose
AUC0-∞: Area under the concentration-time curve extrapolated to infinity
Measured: 192 hours post dose
Frel : Relative bioavailability
calculated as dose-normalised ratio AUC0-t (T)/dose(T) / AUC0-t (R)/dose(R)
Measured: 192 hours post dose
Treatment emergent adverse events (TEAEs)
percentage of subjects with any TEAE
Measured: through study completion up to 46 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start27 Nov 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735030
- Sponsor's protocol ID
- 18CH-hCG09
- Status last verified
- Mar 2021
- First submitted
- 31 Oct 2018
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radicioni M, Leuratti C, Cometti B. Randomized Pharmacokinetic Study of a Highly Purified Human Chorionic Gonadotropin and of a Recombinant Human Chorionic Gonadotropin Following Single Subcutaneous Administration in Healthy Women. Clin Drug Investig. 2022 Mar;42(3):199-206. doi: 10.1007/s40261-022-01118-w. Epub 2022 Feb 9.
PubMed 35137345
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Bioavailability Study of Choriomon® (IBSA) Versus a Marketed hCG Formulation, Following Subcutaneous Administration in Healthy Women. Single-dose, Open-label, Randomized, Two-period, Two-way Cross-over, Bioavailability Study
- ClinicalTrials.gov ID
- NCT03735030
- Acronym / sponsor ID
- 18CH-hCG09
- Conditions
- Infertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study, the rate and extent of hCG absorption will be compared between the two treatments in healthy women aged 20 to 45 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| human hCG | Experimental | Drug: Human hCG 10'000 IU |
| recombinant hCG | Active comparator | Drug: Recombinant hCG 6'500 IU |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Informed consent: signed written informed consent before inclusion in the study;
- Sex and Age: healthy pre-menopausal women, 20-45 years old inclusive;
- Body Mass Index: 18.5-30 kg/m2 inclusive;
- Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position;
- Hormonal oral contraceptives: Combined oral contraceptive pill for at least 2 months before the screening visit;
Key exclusion criteria (14 listed)
- Contraindications: any contraindications to combined oral contraceptive pill or gonadotropins;
- Electrocardiogram 12-leads (supine position): clinically significant abnormalities;
- Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study;
- Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness;
- Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human hCG 10'000 IUA single dose of 10'000 IU of human hCG will be injected in 24 healthy subject volunteers. | Drug | human hCG |
| Recombinant hCG 6'500 IUA single dose of 6'500 IU recombinant hCG will be injected in 24 healthy subject volunteers. | Drug | recombinant hCG |
Primary outcome
Rate of absorption (Cmax)
Time frame: 192 hours post dose
To assess the bioavailability of the test and reference products in terms of rate (baseline-corrected, dose-normalised Cmax) of hCG absorption after single s.c. injection to healthy female subjects.
Extent of absorption (AUC0-t), Area under the concentration-time curve
Time frame: 192 hours post dose
To assess the bioavailability of the test and reference products in terms of extent (baseline-corrected, dose-normalised AUC0-t) of hCG absorption after single s.c. injection to healthy female subjects.Area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
5 secondary outcomes
t1/2: Half-life
Time frame: 192 hours post dose
Tmax: Time to achieve Cmax
Time frame: 192 hours post dose
AUC0-∞: Area under the concentration-time curve extrapolated to infinity
Time frame: 192 hours post dose
Frel : Relative bioavailability
Time frame: 192 hours post dose
Treatment emergent adverse events (TEAEs)
Time frame: through study completion up to 46 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 35137345Radicioni M, Leuratti C, Cometti B. Randomized Pharmacokinetic Study of a Highly Purified Human Chorionic Gonadotropin and of a Recombinant Human Chorionic Gonadotropin Following Single Subcutaneous Administration in Healthy Women. Clin Drug Investig. 2022 Mar;42(3):199-206. doi: 10.1007/s40261-022-01118-w. Epub 2022 Feb 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human hCG 10'000 IU and Recombinant hCG 6'500 IU in people with Infertility, run by IBSA Institut Biochimique SA at 1 site in Switzerland.
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 13 inclusion and 14 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 11 Mar 2021. 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 Switzerland. 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?
Rate of absorption (Cmax) (time frame: 192 hours post dose). 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 NCT03735030, which also lists 1 linked publication.
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 11 Mar 2021; AzTrials last refreshed its copy on 1 Nov 2026.