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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-02

Study Completion Date

2022-08-15

Brief Summary

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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. In China, MENOPUR, 75 IU is approved for controlled ovarian hyperstimulation in relation to assisted reproductive technology (ART). The current trial is intended for supporting marketing authorization approval of a new formulation of MENOPUR in China.

MENOPUR is currently available in China as a powder and solvent for solution for injection, containing 75 IU of FSH and 75 IU of LH activity. A new liquid formulation is developed by Ferring Pharmaceuticals for administration with a disposable pre-filled injection pen, containing 600 IU of FSH and 600 IU of LH activity. MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL is the test product and MENOPUR powder and solvent for solution for injection, 75 IU is the reference product in this trial.

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Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MENOPUR pen

Group Type EXPERIMENTAL

A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL

Intervention Type DRUG

Single dose cross-over bioequivalence trial

MENOPUR powder

Group Type ACTIVE_COMPARATOR

A MENOPUR powder including solvent for solution for injection, 75 IU

Intervention Type DRUG

Single dose cross-over bioequivalence trial

Interventions

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A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL

Single dose cross-over bioequivalence trial

Intervention Type DRUG

A MENOPUR powder including solvent for solution for injection, 75 IU

Single dose cross-over bioequivalence trial

Intervention Type DRUG

Other Intervention Names

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Highly purified menotropin Highly purified menotropin

Eligibility Criteria

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Inclusion Criteria

* 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
* Serum FSH levels ≤5 IU/L and estradiol levels ≤50 pg/mL on Day -3 and Day -1 in TP1

Exclusion Criteria

* 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)
* A history of any medical problems that may prevent use of the combined hormonal contraceptive pill

Minimum Eligible Age

21 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes