Biosimilarity Study of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA).

NCT04605107 | Completed Phase 4 DMC

• 1 other identifier: GRC/1/13/433
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative randomized, single dose, parallel, triple-blinded study in infertile females to evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin (HCG) after Parenteral administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• No. of mature follicles

  A dose of Epifasi 5000 I.U. Ampoule was injected to trigger ovulation., At least, one mature follicle should be detected with a diameter of 18 mm or more \& two additional follicles reached a diameter of 16 mm or more. 34 to 36 hours later oocytes were retrieved.

  Up to 34-36 hours post dose

Secondary Outcomes (1)

• Safety Evaluation

  the patient is observed during the whole course of the study and for one month post study

Study Arms (2)

A test

EXPERIMENTAL

Epifasi 5000 I.U. Ampoules

Drug: Epifasi: Human chorionic gonadotrophin

B reference

ACTIVE COMPARATOR

Pregnyl 5000 I.U. Ampoules

Drug: Pregnyl: Human chorionic gonadotrophin

Interventions

Epifasi: Human chorionic gonadotrophin DRUG

IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin

Also known as: Epifasi

A test

Pregnyl: Human chorionic gonadotrophin DRUG

IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin

Also known as: Pregnyl

B reference

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Infertile and anovulatory females of age 18-40 years, BMI ≤32, Menstrual cycle lasting between 21-35 days, Hormones (FSH, PRL and TSH) within normal levels, two ovaries and a normal uterine cavity and Justified for ART as a result of tubal factor, mild endometriosis, unexplained or male factor.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal woman between 18 - 40 years of age.
• Body mass index (BMI) of 32 or less.
• A menstrual cycle lasting between 21 and 35 days.
• Serum hormone levels of FSH 12 IU/L or less, PRL 1040 mIU/L or less, and TSH within the normal range of 0.3- 4.9 mIU/L
• Patient having both ovaries and a normal uterine cavity confirmed by hysteroscopy, or hysterosalpingography.
• All patients had to be infertile due to at least one of the following causes and must have justified ART (Assisted Reproductive Technology) treatment: tubal factor, mild endometriosis (American Fertility Society classification stage I orII), unexplained infertility, or male factor
• Patients achieving good ovarian response and considered to receive hCG for final follicular maturation prior to OPU.
• Written and signed informed consent by the patient.
• Subject does not have allergy to the drugs under investigation.
• Medical demographics without evidence of clinically significant deviation from rather normal medical condition.

You may not qualify if:

• Patients with low ovarian reserve, as proved by hormonal assays and basal antral follicular count.
• More than three previous assisted reproductive technology cycle or treatment with clomiphene citrate or gonadotropins for at least 1 month before screening,
• Patients with pelvic abnormality that would interfere with ovarian accessibility for OPU, e.g. ovarian endometriotic cysts or high and retro-uterine ovary.
• Patients not achieving a satisfactory ovarian response on ovulation induction, whether poor response (3 or less mature ovarian follicles) or over-response with high likelihood of developing ovarian hyperstimulation syndrome (OHSS) on triggering with HCG.
• History of hypersensitivity to the study medications or to drugs with similar chemical structure.
• Patients unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and likelihood of not completing the study.
• Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
• Subject is on a special diet (for example subject is vegetarian).
• Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
• Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
• Subject has a history of severe diseases which have direct impact on the study.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• EIPICO PHARMA, EGYPT: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, 11757, Egypt

Location

Related Publications (3)

• Steinijans VW, Diletti E. Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals. Eur J Clin Pharmacol. 1983;24(1):127-36. doi: 10.1007/BF00613939.

  PMID: 6832195 BACKGROUND

• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

  PMID: 3450848 BACKGROUND

• Driscoll GL, Tyler JP, Hangan JT, Fisher PR, Birdsall MA, Knight DC. A prospective, randomized, controlled, double-blind, double-dummy comparison of recombinant and urinary HCG for inducing oocyte maturation and follicular luteinization in ovarian stimulation. Hum Reprod. 2000 Jun;15(6):1305-10. doi: 10.1093/humrep/15.6.1305.

  PMID: 10831560 BACKGROUND

Related Links

• International conference of harmonization of technical requirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline. Guidelines for good clinical practice. May 1996.
• The European Agency for the Evaluation of Medicinal products (EMEA). Note for guidance on good clinical practice (CPMP/ICH/135/95), May 1997.
• Guidance for Industry: Bioavailability and Bioequivalence studies for orally administered drug products-general considerations. US Dept. of Health and Human Services, food and drug administration (FDA), center for drug evaluation and research (CDER), M

MeSH Terms

Conditions

Infertility, Female

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 27, 2020
• Study Start: August 30, 2013
• Primary Completion: January 8, 2015
• Study Completion: March 8, 2015
• Last Updated: October 27, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)