CClinicalTrials.gg
CompletedNCT02403401Updated Apr 8, 2021

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

A Phase 3 interventional study of Levonorgestrel (BAY98-7196) in Contraception, sponsored by Bayer. Completed at 100 sites in 2 countries. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2021-04-08.

Sponsored by Bayer · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Jul 2016, 10 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 3
Study type
Interventional
Enrollment
1,471
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Contraception

Keywords

  • Pregnancy prevention
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,471 participants (actual)

Study arms

  • Experimental
    Levonorgestrel (BAY98-7196)

    Vaginal ring containing 170 mg levonorgestrel

    Drug: Levonorgestrel (BAY98-7196)

Interventions

  • DrugLevonorgestrel (BAY98-7196)

    Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)

06

What researchers measure

Primary outcomes

  1. Pregnancy rate (Pearl Index)

    Pearl Index = Number of pregnancies per 100 woman-years of exposure

    Time frame: Up to 12 months

Secondary outcomes

  1. Cumulative failure rate

    Probability of getting pregnant

    Time frame: Up to 12 months

07

Study locations

100 sites
  • Mobile, Alabama 36608, United States
  • Chandler, Arizona 85224, United States
  • Mesa, Arizona 85209, United States
  • Phoenix, Arizona 85032, United States
  • Tucson, Arizona 85710, United States
  • Little Rock, Arkansas 72205, United States
  • La Mesa, California 91942, United States
  • Sacramento, California 95821, United States
  • Sacramento, California 95822, United States
  • San Diego, California 92103, United States
  • San Diego, California 92108, United States
  • San Diego, California 92123, United States
  • Denver, Colorado 80218, United States
  • Denver, Colorado 80220, United States
  • New London, Connecticut 06320, United States
  • Clearwater, Florida 33759, United States
  • Jacksonville, Florida 32216, United States
  • Jupiter, Florida 33458, United States
  • Lake Worth, Florida 33461, United States
  • Leesburg, Florida 34748, United States
  • Miami Beach, Florida 33141, United States
  • Miami, Florida 33186, United States
  • North Miami, Florida 33161, United States
  • Oviedo, Florida 32765, United States
  • Saint Petersburg, Florida 33709, United States
  • Wellington, Florida 33414, United States
  • Atlanta, Georgia 30342, United States
  • Roswell, Georgia 30075, United States
  • Idaho Falls, Idaho 83404, United States
  • Champaign, Illinois 61820, United States
  • Chicago, Illinois 60610, United States
  • Shawnee Mission, Kansas 66218, United States
  • Wichita, Kansas 67207, United States
  • Baltimore, Maryland, United States
  • Lutherville, Maryland 21093, United States
  • Kansas City, Missouri 64114, United States
  • Lincoln, Nebraska 68510, United States
  • Las Vegas, Nevada 89104, United States
  • Las Vegas, Nevada 89109, United States
  • Las Vegas, Nevada 89128, United States
  • Lawrenceville, New Jersey 08648, United States
  • New Brunswick, New Jersey 08901, United States
  • Albuquerque, New Mexico 87109, United States
  • Johnson City, New York 13790, United States
  • Port Jefferson, New York 11777, United States
  • Rochester, New York 14618, United States
  • Williamsville, New York 14221, United States
  • Cary, North Carolina 27518, United States
  • Charlotte, North Carolina 28209, United States
  • Durham, North Carolina 27713, United States
  • Greensboro, North Carolina 27408, United States
  • New Bern, North Carolina 28562, United States
  • Raleigh, North Carolina 27607, United States
  • Raleigh, North Carolina 27612, United States
  • Salisbury, North Carolina 28144, United States
  • Wilmington, North Carolina 28401, United States
  • Winston-Salem, North Carolina 27103, United States
  • Cincinnati, Ohio 45267-0457, United States
  • Cleveland, Ohio 44122, United States
  • Columbus, Ohio 43213, United States
  • Philadelphia, Pennsylvania 19114, United States
  • Pittsburgh, Pennsylvania 15206, United States
  • Pittsburgh, Pennsylvania 15213, United States
  • Columbia, South Carolina 29201, United States
  • Mount Pleasant, South Carolina 29464, United States
  • Myrtle Beach, South Carolina 29572, United States
  • Summerville, South Carolina 29485, United States
  • Jackson, Tennessee 38305-3618, United States
  • Corpus Christi, Texas 78414, United States
  • Houston, Texas 77030, United States
  • Houston, Texas 77074, United States
  • San Antonio, Texas 78229, United States
  • Draper, Utah 84020, United States
  • Pleasant Grove, Utah 84107, United States
  • Salt Lake City, Utah 84107, United States
  • Richmond, Virginia 23233, United States
  • Virginia Beach, Virginia 23456, United States
  • Seattle, Washington 98105, United States
  • Spokane, Washington 99207, United States
  • Funabashi, Chiba 274-0071, Japan
  • Yotsukaido, Chiba 284-0001, Japan
  • Aki-gun, Hiroshima 735-0029, Japan
  • Sapporo, Hokkaido 004-0004, Japan
  • Sapporo, Hokkaido 060-0807, Japan
  • Kurashiki, Okayama 710-0824, Japan
  • Chuo-ku, Tokyo 104-0061, Japan
  • Hachioji, Tokyo 192-0046, Japan
  • Nakano-ku, Tokyo 165-0032, Japan
  • Nishitokyo, Tokyo 188-0011, Japan
  • Ota-ku, Tokyo 144-0052, Japan
  • Setagaya-ku, Tokyo 156-0042, Japan
  • Shinjuku, Tokyo 162-0053, Japan
  • Toshima-ku, Tokyo 171-0021, Japan
  • Fukui, 910-0845, Japan
  • Fukui, 910-0858, Japan
  • Fukui, 910-8561, Japan
  • Fukuoka, 813-0017, Japan
  • Osaka, 530-0013, Japan
  • Osaka, 542-0081, Japan
  • Osaka, 542-0086, Japan
08

References and documents

Publications

  • Nave R, Hochel J, Mellinger U, Kohnke A, Elliesen J, Schmitz H. Pearl Index study with levonorgestrel-releasing intravaginal rings: using pharmacokinetic results to investigate treatment compliance as a potential contributor for contraceptive failure. Hum Reprod. 2020 Nov 1;35(11):2515-2523. doi: 10.1093/humrep/deaa195. PubMed 32914172 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02403401
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 31, 2015
Start date
May 15, 2015
Primary completion
Jul 7, 2016
Completion
Jul 7, 2016
Last update
Apr 8, 2021

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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