Overview

Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation

Status:
Completed
Trial end date:
2019-08-02
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
IBSA Institut Biochimique SA
Treatments:
Chorionic Gonadotropin
Criteria
Inclusion Criteria:

1. Informed consent: signed written informed consent before inclusion in the study;

2. Sex and Age: healthy pre-menopausal women, 20-45 years old inclusive;

3. Body Mass Index: 18.5-30 kg/m2 inclusive;

4. 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;

5. Hormonal oral contraceptives: Combined oral contraceptive pill for at least 2 months
before the screening visit;

6. Menstrual cycle: history of a normal menstrual cycle before combined oral
contraceptive pill use;

7. hCG: endogenous hCG levels <1.2 IU/L at screening and Day -1, Period 1;

8. Pituitary down-regulation: Luteinizing hormone (LH) <5 IU/L; Follicle stimulating
hormone (FSH) <4 IU/L at Day -1, Period 1;

9. Papanicolaou smear (PAP) test: negative or not clinically significant PAP test results
within 12 months before the screening visit or at screening;

10. 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;

11. Additional contraception: study participants with an active sexual life must be using
one additional contraceptive method, as follows:

1. A male sexual partner who agrees to use a male condom with spermicide

2. A sterile sexual partner.

Exclusion Criteria:

1. Contraindications: any contraindications to combined oral contraceptive pill or
gonadotropins;

2. Electrocardiogram 12-leads (supine position): clinically significant abnormalities;

3. Physical findings: clinically significant abnormal physical findings which could
interfere with the objectives of the study;

4. Laboratory analyses: clinically significant abnormal laboratory values indicative of
physical illness;

5. 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;

6. 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;

7. 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;

8. 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;

9. Blood donation: blood donations for 3 months before this study;

10. 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);

11. Drug test: positive result at the drug test at screening or day -1, Period 1;

12. Alcohol test: positive alcohol breath test on day -1;

13. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits
in the 4 weeks before this study; vegetarians;

14. Pregnancy: positive or missing pregnancy test at screening or at day -1 of each
period; pregnant or lactating women.