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).
NCT ID: NCT04605107
Last Updated: 2020-10-27
Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2013-08-30
2015-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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A test
Epifasi 5000 I.U. Ampoules
Epifasi: Human chorionic gonadotrophin
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
B reference
Pregnyl 5000 I.U. Ampoules
Pregnyl: Human chorionic gonadotrophin
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
Interventions
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Epifasi: Human chorionic gonadotrophin
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
Pregnyl: Human chorionic gonadotrophin
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) of 32 or less.
3. A menstrual cycle lasting between 21 and 35 days.
4. 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
5. Patient having both ovaries and a normal uterine cavity confirmed by hysteroscopy, or hysterosalpingography.
6. 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
7. Patients achieving good ovarian response and considered to receive hCG for final follicular maturation prior to OPU.
8. Written and signed informed consent by the patient.
9. Subject does not have allergy to the drugs under investigation.
10. Medical demographics without evidence of clinically significant deviation from rather normal medical condition.
Exclusion Criteria
2. More than three previous assisted reproductive technology cycle or treatment with clomiphene citrate or gonadotropins for at least 1 month before screening,
3. Patients with pelvic abnormality that would interfere with ovarian accessibility for OPU, e.g. ovarian endometriotic cysts or high and retro-uterine ovary.
4. 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.
5. History of hypersensitivity to the study medications or to drugs with similar chemical structure.
6. 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.
7. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
8. Results of laboratory tests which are clinically significant.
9. Acute infection within one week preceding first study drug administration.
10. History of drug or alcohol abuse.
11. 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.
12. Subject is on a special diet (for example subject is vegetarian).
13. 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.
14. 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.
15. Subject has a history of severe diseases which have direct impact on the study.
16. Participation in a biosimilarity study or in a clinical study within the last 6 weeks before first study drug administration.
17. Subject intends to be hospitalized within 3 months after first study drug administration.
18 Years
40 Years
FEMALE
No
Sponsors
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EIPICO PHARMA, EGYPT
UNKNOWN
Genuine Research Center, Egypt
INDUSTRY
Responsible Party
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Principal Investigators
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Ahmed Elshafeey, Ph.D. Pharma
Role: STUDY_DIRECTOR
Genuine Research Center
Locations
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Genuine Research Center GRC
Cairo, , Egypt
Countries
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References
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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.
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.
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.
Related Links
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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
Other Identifiers
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GRC/1/13/433
Identifier Type: -
Identifier Source: org_study_id