• 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 + 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 + dienogest)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Natazia is an estradiol-based oral contraceptive combining estradiol valerate with the progestin dienogest. Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation.

    Natazia is specifically indicated for use by women to prevent pregnancy.

    Natazia is supplied as a tablet for oral administration. Natazia should be taken in the order directed on the blister pack in order to achieve maximum effectiveness. The first Natazia tablet should be taken orally on Day 1 of the menstrual cycle. A non-hormonal contraceptive should be used as back-up during the first 9 days.

    Clinical Results

    FDA Approvals
    The FDA approval of Natazia was based on two multicenter phase III clinical trials in North America and Europe. The Pearl Index (PI) was the primary efficacy endpoint used to assess contraceptive reliability and was assessed in each the two studies, assuming all subjects were at risk of pregnancy unless a back-up contraceptive was used. The PI is based on pregnancies that occurred after the onset of treatment and within 7 days after the last pill intake.
    North America
    This trial enrolled 490 healthy subjects between 18 and 35 years of age with a mean weight of 62.5 kg and a mean BMI of 23.3 kg/m2. The subjects were treated for up to 28 cycles of 28 days each. There were 5 pregnancies within 13 Cycles and 7 days after last treatment. The estimated PI for the North American study was 1.64 and the contraceptive failure rate at the end of the first year was 0.016.
    European Study (Germany, Austria and Spain)
    This study enrolled 1,377 healthy subjects between the ages of 18 and 50 years with an mean weight of 63.8 kg and a mean BMI of 22.8 kg/m2. The subjects were treated for 20 cycles of 28 days each. There were 9 pregnancies within 13 Cycles and 7 days after last treatment. The estimated PI for the European study was 1.04 and the contraceptive failure rate at the end of the first year was 0.010.

    Side Effects

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

    • Headache (including migraines)
    • Metrorrhagia and irregular menstruation
    • Breast pain, discomfort or tenderness
    • Nausea or vomiting
    • Acne
    • Increased weight

    Mechanism of Action

    Natazia is an estradiol-based oral contraceptive combining estradiol valerate with the progestin dienogest. This is the first in a new class of oral contraceptives to deliver estradiol, the estrogen identical to the one produced by the female body. Combination oral contraceptives lower the risk of becoming pregnant primarily by suppressing ovulation. Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implant ation.

    Literature References

    Ahrendt HJ, Makalová D, Parke S, Mellinger U, Mansour D Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception 2009 Nov;80(5):436-44

    Hoy SM, Scott LJ Estradiol valerate/dienogest: in oral contraception. Drugs 2009 Aug 20;69(12):1635-46

    Additional Information

    For additional information regarding Natazia or contraceptives, please visit the Natazia web page.

    Approval Date: 2010-05-01
    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

    • TechInnovation-360x240.png

      Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

    • AskTheExperts-360x240.png

      Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    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