• 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 » Natazia (estradiol valerate and estradiol valerate/dienogest)

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

Natazia (estradiol valerate and estradiol valerate/dienogest)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Natazia is a combined oral contraceptive that contains an estrogen called estradiol valerate in combination with a progestogen called dienogest. Estradiol valerate is converted to estradiol which is the same estrogen produced in a woman’s body.

    Natazia is specifically indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.

    Natazia is supplied as a series of tablets for oral administration. Natazia should be started on Day 1 of the menstrual cycle (the first day of menstrual bleeding). One tablet should be taken orally at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours.

    Clinical Results

    FDA Approval
    The FDA approval of Natazia for heavy menstrual bleeding was based on two identically-designed, multicenter, double-blind, randomized, placebo controlled trials, one in North America and one in Europe and Australia. The studies enrolled a total of 421 adult women with a diagnosis of dysfunctional uterine bleeding characterized as heavy, prolonged and/or frequent bleeding without organic pathology. Heavy menstrual bleeding was defined as menstrual blood loss of 80 mL or more in at least two bleeding episodes during a 90-day run in phase. Subjects were treated for seven 28-day cycles with either Natazia or placebo. The proportion of the intent-to-treat subjects with complete symptom relief (based on 8 strictly defined criteria during the 90-day efficacy assessment phase) was 29.2% in the Natazia group compared to 2.9% in the placebo group in the first study and 29.5% in the Natazia group compared to 1.2% in the placebo group in the second study. The subjects who received Natazia achieved a statistically significant reduction in menstrual blood loss compared with subjects who received placebo (p<0.0001 for both studies).

    Side Effects

    Adverse events associated with the use of Natazia may include, but are not limited to, the following:

    • headache (including migraines)
    • breast pain
    • menstrual disorders
    • nausea or vomiting
    • acne
    • mood changes
    • increased weight

    Mechanism of Action

    Natazia is a combined oral contraceptive that contains an estrogen called estradiol valerate in combination with a progestogen called dienogest. Estradiol valerate is converted to estradiol which is the same estrogen produced in a woman’s body. It has a unique dosing approach with four progestin/estrogen dosing combinations which have been designed to deliver hormones in a novel four-phase estrogen step-down, progestin step-up regimen.

    Additional Information

    For additional information regarding Natazia or heavy menstrual bleeding, please visit the Natazia web page.

    Approval Date: 2012-03-01
    Company Name: Bayer
    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