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

What Was Tested

The trial (phase 1) is built around hCG (human chorionic gonadotropin).

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.

It had two arms (groups): human hCG (experimental) and recombinant hCG (active comparator).

The registry classes the interventions as drug.

Who Took Part

26 actual participants took part.

It was open to women only aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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;.

The full record lists 13 inclusion and 14 exclusion criteria; among the exclusions: contraindications: any contraindications to combined oral contraceptive pill or gonadotropins;; blood donation: blood donations for 3 months before this study;; drug test: positive result at the drug test at screening or day -1, period 1;.

How the Study Was Run

The set-up was randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both hCG (human chorionic gonadotropin) and the comparison in turn, acting as their own control.

Everyone knew when hCG (human chorionic gonadotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2018-11-27 with completion listed for 2019-08-02.

It ran at 1 site in Switzerland.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Rate of absorption (Cmax). Extent of absorption (AUC0-t), Area under the concentration-time curve.

It also tracked 5 secondary outcomes, for example t1/2: Half-life, Tmax: Time to achieve Cmax, AUC0-∞: Area under the concentration-time curve extrapolated to infinity, Frel : Relative bioavailability and Treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of hCG (human chorionic gonadotropin) in 26 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.