Mirena Extension Trial

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Levonorgestrel IUS (Mirena, BAY86-5028)

• Registration Number: NCT02985541
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-07
• Study Start: 2016-12-22
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Results First Submitted: 2022-02-24
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-25
• Last Update Submitted: 2022-04-25
• Results First Posted: 2022-04-28
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 364

Inclusion Criteria

• 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

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levonorgestrel IUS (Mirena, BAY86-5028)	Levonorgestrel IUS (Mirena, BAY86-5028)	Mirena during extended use (Years 6 to 8).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	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).
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	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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Years 6 to 8 of Mirena use	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.