Trial Condition(s):

Contraception

Safety and contraceptive efficacy of an intravaginal ring with LNG (levonorgestrel) over one year in healthy women

Bayer Identifier:

16803

ClinicalTrials.gov Identifier:

NCT02403401

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
1471
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Anastrozole and Levonorgestrel (BAY98-7196)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Sapporo, Japan, 060-0807

Status
Completed
 
Locations

Investigative Site

Yotsukaido, Japan, 284-0001

Status
Completed
 
Locations

Investigative Site

Chuo-ku, Japan, 104-0061

Status
Completed
 
Locations

Investigative Site

Ota-ku, Japan, 144-0052

Status
Completed
 
Locations

Investigative Site

Setagaya-ku, Japan, 156-0042

Status
Completed
 
Locations

Investigative Site

Shinjuku, Japan, 162-0053

Status
Completed
 
Locations

Investigative Site

Nakano-ku, Japan, 165-0032

Status
Completed
 
Locations

Investigative Site

Hachioji, Japan, 192-0046

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 530-0013

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 542-0086

Status
Completed
 
Locations

Investigative Site

Fukui, Japan, 910-0845

Status
Completed
 
Locations

Investigative Site

Fukui, Japan, 910-0858

Status
Completed
 
Locations

Investigative Site

Fukui, Japan, 910-8561

Status
Completed
 
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Investigative Site

Fukuoka, Japan, 813-0017

Status
Completed
 
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Investigative Site

Sapporo, Japan, 004-0004

Status
Completed
 
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Investigative Site

Toshima-ku, Japan, 171-0021

Status
Completed
 
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Investigative Site

Nishitokyo, Japan, 188-0011

Status
Completed
 
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Investigative Site

Funabashi, Japan, 274-0071

Status
Completed
 
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Investigative Site

Osaka, Japan, 542-0081

Status
Completed
 
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Investigative Site

Kurashiki, Japan, 710-0824

Status
Completed
 
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Investigative Site

Aki-gun, Japan, 735-0029

Status
Completed
 
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Baltimore, United States

Status
Completed
 
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Investigative Site

Philadelphia, United States, 19114

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15206

Status
Completed
 
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Investigative Site

Oviedo, United States, 32765

Status
Completed
 
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Investigative Site

Tucson, United States, 85710

Status
Completed
 
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Investigative Site

Wilmington, United States, 28401

Status
Completed
 
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Investigative Site

North Miami, United States, 33161

Status
Completed
 
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Investigative Site

Shawnee, United States, 66218

Status
Completed
 
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Investigative Site

Salt Lake City, United States, 84107

Status
Completed
 
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Rochester, United States, 14618

Status
Completed
 
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Investigative Site

Chandler, United States, 85224

Status
Completed
 
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Port Jefferson, United States, 11777

Status
Completed
 
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Williamsville, United States, 14221

Status
Completed
 
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Investigative Site

Houston, United States, 77030

Status
Completed
 
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Investigative Site

Mesa, United States, 85209

Status
Completed
 
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Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
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Investigative Site

Mobile, United States, 36608

Status
Completed
 
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Investigative Site

Chicago, United States, 60610

Status
Completed
 
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Investigative Site

Little Rock, United States, 72205

Status
Completed
 
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Leesburg, United States, 34748

Status
Completed
 
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Jacksonville, United States, 32216

Status
Completed
 
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Roswell, United States, 30075

Status
Completed
 
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Las Vegas, United States, 89104

Status
Completed
 
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Investigative Site

Phoenix, United States, 85032

Status
Completed
 
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Jupiter, United States, 33458

Status
Completed
 
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Investigative Site

Lawrenceville, United States, 08648

Status
Completed
 
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Investigative Site

Albuquerque, United States, 87109

Status
Completed
 
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Investigative Site

Pleasant Grove, United States, 84107

Status
Completed
 
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Investigative Site

Atlanta, United States, 30342

Status
Completed
 
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Investigative Site

New Brunswick, United States, 08901

Status
Completed
 
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Investigative Site

Raleigh, United States, 27612

Status
Completed
 
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Investigative Site

Denver, United States, 80220

Status
Completed
 
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Investigative Site

San Diego, United States, 92103

Status
Completed
 
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Investigative Site

Corpus Christi, United States, 78414

Status
Completed
 
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Investigative Site

Jackson, United States, 38305-3618

Status
Completed
 
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Investigative Site

Wellington, United States, 33414

Status
Completed
 
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Investigative Site

San Antonio, United States, 78229

Status
Completed
 
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Investigative Site

Las Vegas, United States, 89109

Status
Completed
 
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Investigative Site

Myrtle Beach, United States, 29572

Status
Completed
 
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Investigative Site

Wichita, United States, 67207

Status
Completed
 
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Investigative Site

San Diego, United States, 92108

Status
Completed
 
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Investigative Site

Seattle, United States, 98105

Status
Completed
 
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Investigative Site

Lake Worth, United States, 33461

Status
Completed
 
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Investigative Site

Las Vegas, United States, 89128

Status
Completed
 
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Investigative Site

Spokane, United States, 99207

Status
Completed
 
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Investigative Site

New Bern, United States, 28562

Status
Completed
 
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Investigative Site

Salisbury, United States, 28144

Status
Completed
 
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Investigative Site

Virginia Beach, United States, 23456

Status
Completed
 
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Investigative Site

Charlotte, United States, 28209

Status
Completed
 
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Investigative Site

San Diego, United States, 92123

Status
Completed
 
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Investigative Site

Idaho Falls, United States, 83404

Status
Completed
 
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Investigative Site

Cary, United States, 27518

Status
Completed
 
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Investigative Site

La Mesa, United States, 91942

Status
Completed
 
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Investigative Site

New London, United States, 06320

Status
Completed
 
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Investigative Site

Mt. Pleasant, United States, 29464

Status
Completed
 
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Investigative Site

Cincinnati, United States, 45267-0457

Status
Completed
 
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Investigative Site

Champaign, United States, 61820

Status
Completed
 
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Investigative Site

Denver, United States, 80218

Status
Completed
 
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Investigative Site

Sacramento, United States, 95821

Status
Completed
 
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Investigative Site

Richmond, United States, 23233

Status
Completed
 
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Investigative Site

Lutherville, United States, 21093

Status
Completed
 
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Investigative Site

Summerville, United States, 29485

Status
Completed
 
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Investigative Site

Columbus, United States, 43213

Status
Completed
 
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Investigative Site

Miami Beach, United States, 33141

Status
Completed
 
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Investigative Site

Lincoln, United States, 68510

Status
Completed
 
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Investigative Site

Draper, United States, 84020

Status
Completed
 
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Investigative Site

Clearwater, United States, 33759

Status
Completed
 
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Investigative Site

Miami, United States, 33186

Status
Completed
 
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Investigative Site

Johnson City, United States, 13790

Status
Completed
 
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Investigative Site

Pittsburgh, United States, 15213

Status
Completed
 
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Investigative Site

Sacramento, United States, 95822

Status
Completed
 
Locations

Investigative Site

St. Petersburg, United States, 33709

Status
Completed
 
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Investigative Site

Cleveland, United States, 44122

Status
Completed
 
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Investigative Site

Kansas City, United States, 64114

Status
Completed
 
Locations

Investigative Site

Columbia, United States, 29201

Status
Completed
 
Locations

Investigative Site

Houston, United States, 77074

Status
Completed
 
Locations

Investigative Site

Durham, United States, 27713

Status
Completed
 
Locations

Investigative Site

Raleigh, United States, 27607

Status
Completed
 
Locations

Investigative Site

Greensboro, United States, 27408

Status
Completed
 

Trial Design