Mirena Extension Trial

NCT02985541 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18649
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Contraception

Keywords

Birth Control; Heavy menstrual bleeding

Outcome Measures

Primary Outcomes (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.

  Years 6 to 8 of Mirena use

Secondary Outcomes (3)

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

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

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

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

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

  Years 6 to 8 of Mirena use

Other Outcomes (2)

• Total LNG Concentrations in Plasma Estimated Based on the Final 8-year Population Pharmacokinetics (popPK) Model

  At the beginning of Year 6 (baseline) and at the end of Years 6, 7, and 8 of Mirena use

• Participant's Satisfaction With Mirena by Visit

  Baseline, at end of Year 6, 7 and 8 of Mirena use

Study Arms (1)

Levonorgestrel IUS (Mirena, BAY86-5028)

EXPERIMENTAL

Mirena during extended use (Years 6 to 8).

Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

Interventions

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.

Levonorgestrel IUS (Mirena, BAY86-5028)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (49)

Unknown Facility

Mobile, Alabama, 36608-6703, United States

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Phoenix, Arizona, 85032, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85712, United States

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Encinitas, California, 92024, United States

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San Francisco, California, 94110, United States

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Ventura, California, 93003, United States

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Aurora, Colorado, 80045, United States

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Atlanta, Georgia, 30342, United States

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Idaho Falls, Idaho, 83404, United States

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Fort Wayne, Indiana, 46825, United States

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Newburgh, Indiana, 47630-8940, United States

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Frederick, Maryland, 21702, United States

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Pikesville, Maryland, 21208, United States

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Boston, Massachusetts, 02118, United States

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Saginaw, Michigan, 48604, United States

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Lincoln, Nebraska, 68510, United States

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Las Vegas, Nevada, 89106, United States

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Lebanon, New Hampshire, 03756-1000, United States

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Lawrenceville, New Jersey, 08648, United States

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Neptune City, New Jersey, 07753, United States

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Albuquerque, New Mexico, 87109, United States

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New York, New York, 10032, United States

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Port Jefferson, New York, 11777, United States

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Asheville, North Carolina, 28801, United States

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Durham, North Carolina, 27713, United States

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Greensboro, North Carolina, 27408, United States

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Hickory, North Carolina, 28602, United States

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Morehead City, North Carolina, 28557, United States

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New Bern, North Carolina, 28562, United States

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Winston-Salem, North Carolina, 27103-1749, United States

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Franklin, Ohio, 45005-2593, United States

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Mayfield Heights, Ohio, 44124, United States

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Portland, Oregon, 97239, United States

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Erie, Pennsylvania, 16507, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Chattanooga, Tennessee, 37404, United States

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Austin, Texas, 78758, United States

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Fort Worth, Texas, 76104-4145, United States

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Houston, Texas, 77030, United States

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Draper, Utah, 84020-7163, United States

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Midlothian, Virginia, 23114, United States

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North Chesterfield, Virginia, 23235, United States

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Roanoke, Virginia, 24013-2256, United States

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Virginia Beach, Virginia, 23456, United States

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Seattle, Washington, 98105, United States

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Seattle, Washington, 98122, United States

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Spokane, Washington, 99207-1240, United States

Location

Related Links

• Click here to find results for studies related to Bayer Healthcare products.

MeSH Terms

Conditions

Menorrhagia

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+)1-888-84 22937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 7, 2016
• Study Start: December 22, 2016
• Primary Completion: May 28, 2021
• Study Completion: May 28, 2021
• Last Updated: April 28, 2022
• Results First Posted: April 28, 2022

Record last verified: 2022-04

Locations

US (49)