A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women

What Was Tested

This registered phase 1 trial tested HMG (Human Menopausal Gonadotropin).

MENOPUR is a human menotrophin product, with a combination of human follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity.

Human chorionic gonadotrophin (hCG) is the major contributor to the LH activity in the product.

MENOPUR is approved in more than 130 countries for a variety of strengths and indications.

It had two arms (groups): MENOPUR pen (experimental) and MENOPUR powder (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 95 actual participants took part.

It was open to women only aged from 21 years up to 40 years.

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

Examples of who could join: Chinese women between the ages of 21 to 40 years at the time of signing the informed consent form. Non-users or users of the combined oral contraceptive (COC) pill who describe experiencing menstrual cycles of 24 to 35 days in duration (both inclusive). Healthy according to medical history, physical and gynecological examinations, vital signs, 12-lead electrocardiogram, and laboratory tests in blood and urine.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: any finding at the gynecological examination, transvaginal ultrasound or by cervical smear that is considered medically important; A history of medical problems that could affect the functioning of the reproductive organs (ovaries and womb).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

The participants were allocated by chance, so the HMG (Human Menopausal Gonadotropin) group and the comparison group should start out alike.

In the crossover set-up each of the participants took both HMG (Human Menopausal Gonadotropin) and the comparison in turn, acting as their own control.

Nothing was hidden in this open-label HMG (Human Menopausal Gonadotropin) study: the participants and staff both knew the treatment.

It started in 2021-11-02 with completion listed for 2022-08-15.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 58 secondary outcomes, for example Frequency of adverse events (AEs) stratified by intensity, Frequency of injection site reactions stratified by intensity, Change from baseline of vital signs (systolic and diastolic blood pressure), Change from baseline of vital sign (pulse), Change from baseline of vital sign (body temperature) and Change from baseline of 12-lead electrocardiogram (ECG): Heart rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of HMG (Human Menopausal Gonadotropin) in 95 people.

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

More context: the HMG (Human Menopausal Gonadotropin) compound page, all human trials.