• 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
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • 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 » Crinone 8% (progesterone gel)

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

Crinone 8% (progesterone gel)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Crinone has been approved for use as a progesterone supplementation or replacement. It is indicated as a treatment for infertile women with progesterone deficiency. Crinone is used in conjunction with assisted reproductive technology--in-vitro fertilization, ovum donation and stimulated cycles.

    It is the first product to deliver progesterone directly to the uterus in a bioadhesive gel. Previously, products available were only administered via intramuscular injections or suppositories.

    Clinical Results

    In a progesterone replacement clinical study, women requiring progesterone replacement were administered Crinone 8% at a dose of one applicator (90mg) twice daily. Of the 54 women who underwent an embryo transfer and were treated with crinone, 48% achieved a clinical pregnancy, and 31% delivered.

    In a progesterone supplement clinical study, women requiring progesterone supplementation were evaluated following an in-vitro fertilization procedure. In this study, patients received one applicator (90mg) of crinone once daily. Of the 139 patients who received an embryo, 26% achieved a clinical pregnancy and 23% delivered.

    Side Effects

    In women requiring progesterone replacement, the most frequently reported side effects were cramps, breast pain, and headache. In women requiring progestereone supplementation, the most frequently reported side effects were breast enlargement, constipation, somnolence, nausea, and headache.

    Women with the following conditions should not use progesterone therapy: a known sensitivity to progesterone, undiagnosed vaginal bleeding, liver dysfunction or disease, known or suspected malignancy of the breast or genital organs, a recent miscarriage with suspected tissue remaining in the uterus, or history of blood clots.

    Approval Date: 1997-05-01
    Company Name: Wyeth
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • Virtual Doctoer

      Simple Changes Can Make Trials More Patient Friendly

    • Drug approval

      Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S.

    • VaccinewithNeedle-360x240.png

      Rules of Vaccine Approval May Be Changing, But Statistical Analysis Tools Remain Constant

    • AskTheExperts-360x240.png

      Ask the Experts: Trial Operations Adjustments in a Remote World

    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 © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing