DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel (BAY98-7196) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Summary

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

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Pregnancy rate (Pearl Index)

Eligibility

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Fukui 910-0858, Japan; Not yet recruiting

Fukui 910-8561, Japan; Not yet recruiting

Fukui 910-0845, Japan; Not yet recruiting

Fukuoka 813-0017, Japan; Not yet recruiting

Kagoshima 890-0055, Japan; Not yet recruiting

Kagoshima 892-0816, Japan; Terminated

Osaka 542-0086, Japan; Not yet recruiting

Osaka 530-0013, Japan; Not yet recruiting

Osaka 542-0081, Japan; Not yet recruiting

Mobile, Alabama 36608, United States; Recruiting

Chandler, Arizona 85224, United States; Recruiting

Mesa, Arizona 85209, United States; Recruiting

Phoenix, Arizona 85032, United States; Not yet recruiting

Tucson, Arizona 85710, United States; Recruiting

Little Rock, Arkansas 72205, United States; Not yet recruiting

La Mesa, California 91942, United States; Recruiting

Sacramento, California 95821, United States; Recruiting

Sacramento, California 95822, United States; Recruiting

San Diego, California 92103, United States; Recruiting

San Diego, California 92108, United States; Recruiting

San Diego, California 92123, United States; Not yet recruiting

Funabashi, Chiba 274-0071, Japan; Not yet recruiting

Yotsukaido, Chiba 284-0001, Japan; Not yet recruiting

Denver, Colorado 80218, United States; Recruiting

Denver, Colorado 80220, United States; Recruiting

New London, Connecticut 06320, United States; Not yet recruiting

Clearwater, Florida 33759, United States; Recruiting

Jacksonville, Florida 32216, United States; Recruiting

Jupiter, Florida 33458, United States; Recruiting

Lake Worth, Florida 33461, United States; Not yet recruiting

Leesburg, Florida 34748, United States; Recruiting

Miami Beach, Florida 33141, United States; Not yet recruiting

Miami, Florida 33186, United States; Recruiting

North Miami, Florida 33161, United States; Recruiting

Oviedo, Florida 32765, United States; Not yet recruiting

St. Petersburg, Florida 33709, United States; Not yet recruiting

Wellington, Florida 33414, United States; Recruiting

Yanagawa, Fukuoka 832-0077, Japan; Not yet recruiting

Atlanta, Georgia 30342, United States; Recruiting

Roswell, Georgia 30075, United States; Not yet recruiting

Aki-gun, Hiroshima 735-0029, Japan; Not yet recruiting

Asahikawa, Hokkaido 070-8003, Japan; Not yet recruiting

Sapporo, Hokkaido 060-0807, Japan; Not yet recruiting

Sapporo, Hokkaido 004-0004, Japan; Not yet recruiting

Idaho Falls, Idaho 83404, United States; Recruiting

Champaign, Illinois 61820, United States; Recruiting

Chicago, Illinois 60610, United States; Not yet recruiting

Yokohama, Kanagawa 230-0001, Japan; Not yet recruiting

Shawnee, Kansas 66218, United States; Not yet recruiting

Wichita, Kansas 67207, United States; Recruiting

Annapolis, Maryland 21401, United States; Not yet recruiting

Baltimore, Maryland, United States; Not yet recruiting

Lutherville, Maryland 21093, United States; Not yet recruiting

Saginaw, Michigan 48604, United States; Not yet recruiting

Kansas City, Missouri 64114, United States; Not yet recruiting

Lincoln, Nebraska 68510, United States; Recruiting

Las Vegas, Nevada 89104, United States; Recruiting

Las Vegas, Nevada 89128, United States; Not yet recruiting

Las Vegas, Nevada 89109, United States; Not yet recruiting

Lawrenceville, New Jersey 08648, United States; Recruiting

New Brunswick, New Jersey 08901, United States; Not yet recruiting

Albuquerque, New Mexico 87109, United States; Recruiting

Johnson City, New York 13790, United States; Recruiting

Port Jefferson, New York 11777, United States; Not yet recruiting

Rochester, New York 14618, United States; Recruiting

Williamsville, New York 14221, United States; Not yet recruiting

Cary, North Carolina 27518, United States; Not yet recruiting

Charlotte, North Carolina 28209, United States; Not yet recruiting

New Bern, North Carolina 28562, United States; Not yet recruiting

Raleigh, North Carolina 27612, United States; Not yet recruiting

Salisbury, North Carolina 28144, United States; Not yet recruiting

Wilmington, North Carolina 28401, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Recruiting

Winston-Salem, North Carolina 27103, United States; Not yet recruiting

Cincinnati, Ohio 45267-0457, United States; Not yet recruiting

Cleveland, Ohio 44122, United States; Recruiting

Columbus, Ohio 43213, United States; Not yet recruiting

Kurashiki, Okayama 710-0824, Japan; Not yet recruiting

Philadelphia, Pennsylvania 19114, United States; Recruiting

Pittsburgh, Pennsylvania 15206, United States; Not yet recruiting

Pittsburgh, Pennsylvania 15213, United States; Not yet recruiting

Mt. Pleasant, South Carolina 29464, United States; Not yet recruiting

Myrtle Beach, South Carolina 29572, United States; Recruiting

Summerville, South Carolina 29485, United States; Not yet recruiting

Jackson, Tennessee 38305-3618, United States; Not yet recruiting

Corpus Christi, Texas 78414, United States; Not yet recruiting

Houston, Texas 77030, United States; Not yet recruiting

San Antonio, Texas 78229, United States; Not yet recruiting

Chiyoda-ku, Tokyo 101-0062, Japan; Not yet recruiting

Chuo-ku, Tokyo 104-0061, Japan; Not yet recruiting

Hachioji, Tokyo 192-0046, Japan; Not yet recruiting

Minato-ku, Tokyo 108-8642, Japan; Not yet recruiting

Nakano-ku, Tokyo 165-0032, Japan; Not yet recruiting

Nishitokyo, Tokyo 188-0011, Japan; Not yet recruiting

Ota-ku, Tokyo 144-0052, Japan; Not yet recruiting

Setagaya-ku, Tokyo 156-0042, Japan; Not yet recruiting

Shinjuku, Tokyo 162-0053, Japan; Not yet recruiting

Toshima-ku, Tokyo 171-0021, Japan; Not yet recruiting

Draper, Utah 84020, United States; Recruiting

Pleasant Grove, Utah 84107, United States; Not yet recruiting

Salt Lake City, Utah 84107, United States; Recruiting

Richmond, Virginia 23233, United States; Recruiting

Virginia Beach, Virginia 23456, United States; Not yet recruiting

Seattle, Washington 98105, United States; Recruiting

Spokane, Washington 99207, United States; Recruiting

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: May 2015
Last updated: July 24, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017