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ContraceptionPhase 3NCT02403401

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

A Phase 3 study testing Levonorgestrel (BAY98-7196) in people with Contraception, run by Bayer at 100 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Contraception
What is being tested?
Levonorgestrel (BAY98-7196)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,471 participants
Where
100 sitesin 2 countries
Study dates
15 May 2015to 7 Jul 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

100 sites in 2 countries.

100 sites in 2 countries

United States79 sites

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Baltimore, Maryland

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Champaign, Illinois, 61820

  • Study site

    Chandler, Arizona, 85224

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chicago, Illinois, 60610

  • Study site

    Cincinnati, Ohio, 45267-0457

  • Study site

    Clearwater, Florida, 33759

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Columbia, South Carolina, 29201

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Denver, Colorado, 80218

  • Study site

    Denver, Colorado, 80220

  • Study site

    Draper, Utah, 84020

  • Study site

    Durham, North Carolina, 27713

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Houston, Texas, 77030

  • Study site

    Houston, Texas, 77074

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Jackson, Tennessee, 38305-3618

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Johnson City, New York, 13790

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    La Mesa, California, 91942

  • Study site

    Lake Worth, Florida, 33461

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Las Vegas, Nevada, 89128

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Leesburg, Florida, 34748

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Mesa, Arizona, 85209

  • Study site

    Miami, Florida, 33186

  • Study site

    Miami Beach, Florida, 33141

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Myrtle Beach, South Carolina, 29572

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New London, Connecticut, 06320

  • Study site

    North Miami, Florida, 33161

  • Study site

    Oviedo, Florida, 32765

  • Study site

    Philadelphia, Pennsylvania, 19114

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pleasant Grove, Utah, 84107

  • Study site

    Port Jefferson, New York, 11777

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Richmond, Virginia, 23233

  • Study site

    Rochester, New York, 14618

  • Study site

    Roswell, Georgia, 30075

  • Study site

    Sacramento, California, 95821

  • Study site

    Sacramento, California, 95822

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92123

  • Study site

    Seattle, Washington, 98105

  • Study site

    Shawnee Mission, Kansas, 66218

  • Study site

    Spokane, Washington, 99207

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Summerville, South Carolina, 29485

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Virginia Beach, Virginia, 23456

  • Study site

    Wellington, Florida, 33414

  • Study site

    Wichita, Kansas, 67207

  • Study site

    Williamsville, New York, 14221

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan21 sites

  • Study site

    Aki-gun, Hiroshima, 735-0029

  • Study site

    Chuo-ku, Tokyo, 104-0061

  • Study site

    Fukui, 910-0845

  • Study site

    Fukui, 910-0858

  • Study site

    Fukui, 910-8561

  • Study site

    Fukuoka, 813-0017

  • Study site

    Funabashi, Chiba, 274-0071

  • Study site

    Hachiōji, Tokyo, 192-0046

  • Study site

    Kurashiki, Okayama-ken, 710-0824

  • Study site

    Nakano-ku, Tokyo, 165-0032

  • Study site

    Nishitōkyō, Tokyo, 188-0011

  • Study site

    Osaka, 530-0013

  • Study site

    Osaka, 542-0081

  • Study site

    Osaka, 542-0086

  • Study site

    Ōta-ku, Tokyo, 144-0052

  • Study site

    Sapporo, Hokkaido, 004-0004

  • Study site

    Sapporo, Hokkaido, 060-0807

  • Study site

    Setagaya-ku, Tokyo, 156-0042

  • Study site

    Shinjuku, Tokyo, 162-0053

  • Study site

    Toshima-ku, Tokyo, 171-0021

  • Study site

    Yotsukaidō, Chiba, 284-0001

Other trials in Japan

About this study

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

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

Conditions
Contraception
Being tested
Levonorgestrel (BAY98-7196)
Keywords
Pregnancy prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levonorgestrel (BAY98-7196)Drug

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

Study groups in NCT02403401
Study groupRoleWhat they receive
Levonorgestrel (BAY98-7196)ExperimentalVaginal ring containing 170 mg levonorgestrel
Receives: Drug: Levonorgestrel (BAY98-7196)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pregnancy rate (Pearl Index)

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

    Measured: Up to 12 months

Secondary outcomes (1)

  1. Cumulative failure rate

    Probability of getting pregnant

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study start15 May 2015
  3. Primary completion7 Jul 2016
  4. Study completion7 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,471 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403401
Sponsor's protocol ID
16803
Status last verified
Apr 2021
First submitted
26 Mar 2015
Last updated
8 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levonorgestrel (BAY98-7196) in people with Contraception, run by Bayer at 100 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pregnancy rate (Pearl Index) (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02403401, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.

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