Safety and Contraceptive Efficacy of an Intravaginal Ring With LNG (Levonorgestrel) Over One Year in Healthy Women

April 6, 2021 updated by: Bayer

Multi-center, Open-label, Single-arm Study to Assess the Safety and Contraceptive Efficacy of a Levonorgestrel-containing Intravaginal Ring During a Treatment Period of One Year in Healthy Women 18 to 35 Years of Age

Purpose of the study is to investigate safety and contraceptive efficacy of an LNG-containing intravaginal ring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1471

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukui, Japan, 910-8561
      • Fukui, Japan, 910-0845
      • Fukui, Japan, 910-0858
      • Fukuoka, Japan, 813-0017
      • Osaka, Japan, 530-0013
      • Osaka, Japan, 542-0086
      • Osaka, Japan, 542-0081
    • Chiba
      • Funabashi, Chiba, Japan, 274-0071
      • Yotsukaido, Chiba, Japan, 284-0001
    • Hiroshima
      • Aki-gun, Hiroshima, Japan, 735-0029
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0807
      • Sapporo, Hokkaido, Japan, 004-0004
    • Okayama
      • Kurashiki, Okayama, Japan, 710-0824
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0061
      • Hachioji, Tokyo, Japan, 192-0046
      • Nakano-ku, Tokyo, Japan, 165-0032
      • Nishitokyo, Tokyo, Japan, 188-0011
      • Ota-ku, Tokyo, Japan, 144-0052
      • Setagaya-ku, Tokyo, Japan, 156-0042
      • Shinjuku, Tokyo, Japan, 162-0053
      • Toshima-ku, Tokyo, Japan, 171-0021
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Mesa, Arizona, United States, 85209
      • Phoenix, Arizona, United States, 85032
      • Tucson, Arizona, United States, 85710
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • La Mesa, California, United States, 91942
      • Sacramento, California, United States, 95821
      • Sacramento, California, United States, 95822
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
    • Colorado
      • Denver, Colorado, United States, 80218
      • Denver, Colorado, United States, 80220
    • Connecticut
      • New London, Connecticut, United States, 06320
    • Florida
      • Clearwater, Florida, United States, 33759
      • Jacksonville, Florida, United States, 32216
      • Jupiter, Florida, United States, 33458
      • Lake Worth, Florida, United States, 33461
      • Leesburg, Florida, United States, 34748
      • Miami, Florida, United States, 33186
      • Miami Beach, Florida, United States, 33141
      • North Miami, Florida, United States, 33161
      • Oviedo, Florida, United States, 32765
      • Saint Petersburg, Florida, United States, 33709
      • Wellington, Florida, United States, 33414
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Roswell, Georgia, United States, 30075
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Champaign, Illinois, United States, 61820
      • Chicago, Illinois, United States, 60610
    • Kansas
      • Shawnee Mission, Kansas, United States, 66218
      • Wichita, Kansas, United States, 67207
    • Maryland
      • Baltimore, Maryland, United States
      • Lutherville, Maryland, United States, 21093
    • Missouri
      • Kansas City, Missouri, United States, 64114
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Las Vegas, Nevada, United States, 89109
      • Las Vegas, Nevada, United States, 89128
      • Las Vegas, Nevada, United States, 89104
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
      • New Brunswick, New Jersey, United States, 08901
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • Johnson City, New York, United States, 13790
      • Port Jefferson, New York, United States, 11777
      • Rochester, New York, United States, 14618
      • Williamsville, New York, United States, 14221
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Charlotte, North Carolina, United States, 28209
      • Durham, North Carolina, United States, 27713
      • Greensboro, North Carolina, United States, 27408
      • New Bern, North Carolina, United States, 28562
      • Raleigh, North Carolina, United States, 27607
      • Raleigh, North Carolina, United States, 27612
      • Salisbury, North Carolina, United States, 28144
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0457
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43213
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15206
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Columbia, South Carolina, United States, 29201
      • Mount Pleasant, South Carolina, United States, 29464
      • Myrtle Beach, South Carolina, United States, 29572
      • Summerville, South Carolina, United States, 29485
    • Tennessee
      • Jackson, Tennessee, United States, 38305-3618
    • Texas
      • Corpus Christi, Texas, United States, 78414
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77074
      • San Antonio, Texas, United States, 78229
    • Utah
      • Draper, Utah, United States, 84020
      • Pleasant Grove, Utah, United States, 84107
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Richmond, Virginia, United States, 23233
      • Virginia Beach, Virginia, United States, 23456
    • Washington
      • Seattle, Washington, United States, 98105
      • Spokane, Washington, United States, 99207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy female subject requesting contraception and willing to use the IVR
  • Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months)
  • History of regular cyclic menstrual periods
  • Subject is willing and able to attend the scheduled study visits and comply with study procedures

Exclusion Criteria:

  • Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment)
  • Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug
  • Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
  • Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator
  • Undiagnosed abnormal genital bleeding
  • Wish for pregnancy during the study
  • Major surgery scheduled during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levonorgestrel (BAY98-7196)
Vaginal ring containing 170 mg levonorgestrel
Drug: Levonorgestrel (BAY98-7196)
Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate (Pearl Index)
Time Frame: Up to 12 months
Pearl Index = Number of pregnancies per 100 woman-years of exposure
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative failure rate
Time Frame: Up to 12 months
Probability of getting pregnant
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2015

Primary Completion (Actual)

July 7, 2016

Study Completion (Actual)

July 7, 2016

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 26, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16803

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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