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ContraceptionPhase 3METNCT02985541

Mirena Extension Trial

A Phase 3 study testing Levonorgestrel IUS (Mirena, BAY86-5028) in people with Contraception, run by Bayer at 49 sites in United States.

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

The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding [HMB]) and safety will be assessed. 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 IUS (Mirena, BAY86-5028)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
364 participants
Where
49 sitesUnited States
Study dates
22 Dec 2016to 28 May 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed and dated informed consent
  • Women, 18 to 35 years of age at the time of screening (visit 1) who are currently using Mirena for contraception or for contraception and heavy menstrual bleeding. The duration of use of the current Mirena has to be at least 4 years 6 months at the start of screening phase but not more than 5 years at visit 2 and the woman is willing to continue with its use and has a continuing need for contraception.
  • Normal or clinically insignificant cervical smear not requiring further follow up

Who cannot join

  • Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml
  • Pregnancy or suspicion of pregnancy
  • Uterine bleeding of unknown etiology
  • Untreated acute cervicitis or vaginitis or other lower genital tract infections
  • Increased susceptibility to pelvic infection
  • Acute pelvic inflammatory disease (PID) or a history of PID unless successfully treated and which, in the investigator's opinion, has not negatively affected subject's fertility
Show all 10Show fewer
  • Congenital or acquired uterine anomaly if it distorts the uterine cavity
  • History of, diagnosed or suspected genital or other malignancy and untreated cervical dysplasia
  • Any active acute liver disease or liver tumor (benign or malignant)
  • Clinically significant endometrial polyp(s)

Trial locations and contacts

49 sites in 1 country.

49 sites in 1 country

United States49 sites

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Asheville, North Carolina, 28801

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78758

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Draper, Utah, 84020-7163

  • Study site

    Durham, North Carolina, 27713

  • Study site

    Encinitas, California, 92024

  • Study site

    Erie, Pennsylvania, 16507

  • Study site

    Fort Wayne, Indiana, 46825

  • Study site

    Fort Worth, Texas, 76104-4145

  • Study site

    Franklin, Ohio, 45005-2593

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Greensboro, North Carolina, 27408

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Houston, Texas, 77030

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Lebanon, New Hampshire, 03756-1000

  • Study site

    Lincoln, Nebraska, 68510

  • Study site

    Mayfield Heights, Ohio, 44124

  • Study site

    Midlothian, Virginia, 23114

  • Study site

    Mobile, Alabama, 36608-6703

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Neptune City, New Jersey, 07753

  • Study site

    New Bern, North Carolina, 28562

  • Study site

    New York, New York, 10032

  • Study site

    Newburgh, Indiana, 47630-8940

  • Study site

    North Chesterfield, Virginia, 23235

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85032

  • Study site

    Pikesville, Maryland, 21208

  • Study site

    Port Jefferson, New York, 11777

  • Study site

    Portland, Oregon, 97239

  • Study site

    Roanoke, Virginia, 24013-2256

  • Study site

    Saginaw, Michigan, 48604

  • Study site

    San Francisco, California, 94110

  • Study site

    Scottsdale, Arizona, 85251

  • Study site

    Seattle, Washington, 98105

  • Study site

    Seattle, Washington, 98122

  • Study site

    Spokane, Washington, 99207-1240

  • Study site

    Tucson, Arizona, 85712

  • Study site

    Ventura, California, 93003

  • Study site

    Virginia Beach, Virginia, 23456

  • Study site

    Winston-Salem, North Carolina, 27103-1749

Other trials in United States

About this study

Official title: Multi-center, Open-label, Uncontrolled Study to Assess Contraceptive Efficacy and Safety of Mirena During Extended Use Beyond 5 Years in Women 18 to 35 Years of Age Including a Subgroup Evaluation of Treatment Effect on Heavy Menstrual Bleeding

The study is performed to assess if Mirena is effective and safe as a birth control method beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.

Conditions
Contraception
Being tested
Levonorgestrel IUS (Mirena, BAY86-5028)
Keywords
Birth Control, Heavy menstrual bleeding
Medical subject headings
Menorrhagia

What participants receive

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

  • Levonorgestrel IUS (Mirena, BAY86-5028)Drug

    Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.

Study groups in NCT02985541
Study groupRoleWhat they receive
Levonorgestrel IUS (Mirena, BAY86-5028)ExperimentalMirena during extended use (Years 6 to 8).
Receives: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

What is being measured

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

  1. Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use

    The Pearl Index (PI) is defined as the number of pregnancies per 100 women years. The 3-year PI (Years 6 to 8) was obtained by dividing the number of pregnancies the occurred during that time (starting at Day 1 Year 6 and up to Day 365 of Year 8) by the time (in 100 women years) that the women were at risk of getting pregnant during that time.

    Measured: Years 6 to 8 of Mirena use

Secondary outcomes (3)

  1. Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8

    Menstrual blood loss (MBL) during a 30-day period starting at the baseline visit and at the end of Year 6, Year 7, and Year 8, measured by the alkaline hematin method. The assessment of this variable was restricted to women who had Mirena inserted for heavy menstrual bleeding (HMB).

    Measured: Baseline and end of Years 6, 7 and 8 of Mirena use

  2. Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use

    Categorized menstrual blood loss (MBL) (≥ 80 mL per 30 days) at end of Year 6, Year 7, and Year 8. The assessment of this variable was restricted to women who had Mirena inserted for HMB.

    Measured: At end of Year 6, 7 and 8 of Mirena use

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Adverse event (AE) was defined as any untoward medical occurrence (ie any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a patient or clinical investigation subject after providing written informed consent for participation in the study. Serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose 1) resulted in death, 2) was life-threatening, 3) required inpatient hospitalization or prolongation of existing hospitalization, 4) resulted in persistent or significant disability/incapacity, 5) was a congenital anomaly/birth defect, or 6) was another medically important serious event as judged by the investigator. Treatment-emergent adverse event (TEAE) was defined as an AE that occurred on Day 1 Year 6 of Mirena use or later.

    Measured: Years 6 to 8 of Mirena use

Timeline

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

  1. First posted7 Dec 2016 (estimated)
  2. Study start22 Dec 2016
  3. Primary completion28 May 2021
  4. Study completion28 May 2021

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02985541
Sponsor's protocol ID
18649
Acronym
MET
Status last verified
Apr 2022
First submitted
5 Dec 2016
Last updated
28 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levonorgestrel IUS (Mirena, BAY86-5028) in people with Contraception, run by Bayer at 49 sites in United States.

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 3 inclusion and 10 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 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. 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?

Yes. Results are posted in the registry (first posted 28 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use (time frame: Years 6 to 8 of Mirena use). 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 NCT02985541.

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 28 Apr 2022.

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