• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Gonal-F (follitropin alfa for injection)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Gonal-F (follitropin alfa for injection)

  • Profile

Profile

Contact Information

Contact: EMD Serono
Website: https://www.emdserono.com/us-en/expertise/fertility.html

Currently Enrolling Trials

    Show More

    General Information

    Gonal-F (follitropin alfa for injection) is a gonadotropin.

    Gonal-F is specifically indicated for:

    • Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure.
    • Development of multiple follicles in ovulatory infertile women as part of Assisted Reproductive Technology (ART) cycles.

    The recommended dosing is as follows:

    Induction of Ovulation

    Initial starting dose of the first cycle: 75 International Units of Gonal-F per day for 14 days, administered subcutaneously. Individualize doses after 14 days. Do not administer doses greater than 300 International Units per day

    Development of Multiple Follicles in Assisted Reproductive Technology (ART)

    Initial starting dose of the first cycle: 150 International Units per day, administered subcutaneously. Dosage adjustments after 3 to 5 days and by 75 to 150 International Units at each adjustment. Do not administer doses greater than 450 International Units per day

    Mechanism of Action

    Gonal-F (follitropin alfa for injection) is a gonadotropin. Gonal-F stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of Gonal-F, when monitoring of the patient indicates that sufficient follicular development is achieved.

    Side Effects

    Adverse effects associated with the use of Gonal-F in ovulation induction may include, but are not limited to, the following:

    • headache
    • abdominal pain
    • ovarian hyperstimulation
    • injection site pain
    • diarrhea
    • flatulence
    • nausea
    • ovarian cyst
    • injection site inflammation.

    Adverse effects associated with the use of Gonal-F in development of multiple follicles in AR may include, but are not limited to, the following:

    • abdominal pain
    • headache
    • abdominal enlargement
    • injection site bruising
    • nausea
    • injection site pain
    • ovarian hyperstimulation
    • injection site inflammation
    • injection site reaction
    • injection site edema

    Clinical Trial Results

    ​​​Induction of Ovulation was evaluated in a randomized, assessor-blind, multinational, multicenter, active-controlled trial in oligo-anovulatory infertile women. Women were randomized to either Gonal-F (n=83), administered subcutaneously, or a comparator recombinant human FSH product. The use of insulin-sensitizing agents was allowed during the trial. The trial was designed to evaluate and compare mean ovulation rates in the first cycle of treatment.

    Cycle Cumulative Percent Ovulation Cumulative Clinical Pregnancy Rate
    1 72% 28%
    2 89% 41%
    3 92% 45%

    Development of Multiple Follicles as part of an Assisted Reproductive Technology (ART) Cycle

    The efficacy of Gonal-F was evaluated in a randomized, assessor-blind, multinational, multicenter active-controlled trial in ovulatory, infertile women treated for one cycle with controlled ovarian stimulation as part of an ART [in vitro fertilization (IVF), or intracytoplasmic sperm injection (ICSI)] cycle. Women were randomized to either Gonal-F (n=237), administered subcutaneously, or a comparator recombinant human FSH product. Randomization was stratified by insemination technique (IVF versus ICSI). All women received a GnRH agonist for pituitary down-regulation before receiving stimulation with recombinant FSH. The primary endpoint was the mean number of fertilized oocytes the day after insemination. The initial doses of Gonal-F were 150 International Units per day for women less than 35 years of age and 225 International Units per day for women 35 years of age and older. The maximal dose given for both age groups was 450 International Units per day. 

    Trial Outcome value (n)
    Mean number of 2PN oocytes per woman 6.3 (237)
    Mean number of 2PN oocytes per woman receiving IVF  6.1 (88)
    Mean number of 2PN oocytes per woman receiving ICS 6.5 (132)
    Clinical pregnancy rate per attempt 33.5% (218)
    Clinical pregnancy rate per embryo transfer  35.8% (204)
    Mean treatment duration in days (range)  9.7 [3-21] (230)

     

    Approval Date: 1997-09-01
    Company Name: EMD Serono
    Back to Listings

    Upcoming Events

    • 24May

      Powering an Effective Oversight Strategy with Clinical and Operational Insights

    • 25May

      2022 WCG Avoca Quality & Innovation Summit: Own the Future

    • 28Jun

      Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

    • 16Oct

      WCG MAGI's Clinical Research Hybrid Conference - 2022 West

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Protocol-360x240.png

      Avoid Deviations by Making Protocol Review a Team Effort

    • SelectionProcess-360x240.png

      Give Us a Voice: Sites Clamor for a Say on Vendor Selection

    • Convince-360x240.png

      Use Data and Details to Convince Site Leadership to Add Staff

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing