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

NCT04902131 | Completed Phase 1

• 1 other identifier: 000347
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameter of FSH: AUCt

  AUCt is defined as area under the concentration-time curve from dosing to the last time point when the baseline adjusted concentration is above zero.

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before investigational medicinal product [IMP] administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

• Pharmacokinetic parameter of FSH: Cmax

  Cmax is defined as baseline adjusted maximum observed concentration.

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

Secondary Outcomes (58)

• Pharmacokinetic parameter of FSH: AUCinf

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

• Pharmacokinetic parameter of FSH: Tmax

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

• Pharmacokinetic parameter of FSH: CL/F

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

• Pharmacokinetic parameter of FSH: Vz/F

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

• Pharmacokinetic parameter of FSH: λz

  At -1, -0.5 hours pre-dose, and immediately pre-dose (within 10 min before IMP administration), and at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 72, 96, 120, 168 and 216 hours after administration

Study Arms (2)

MENOPUR pen

EXPERIMENTAL

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

MENOPUR powder

ACTIVE COMPARATOR

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

Interventions

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

Single dose cross-over bioequivalence trial

Also known as: Highly purified menotropin

MENOPUR pen

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

Single dose cross-over bioequivalence trial

Also known as: Highly purified menotropin

MENOPUR powder

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Healthy women, 21 to 40 years of age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (2)

Ferring investigational site

Nanjing, Gaoxin District, 210032, China

Location

Ferring investigational site

Nanjing, 210029, China

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Injections; Solutions

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pharmaceutical Preparations

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 26, 2021
• Study Start: November 2, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: August 24, 2022

Record last verified: 2022-05

Locations

CN (2)