Phase 3
Completed N=364
Mirena Extension Trial
Source: ClinicalTrials.gov NCT02985541 ↗Enrolled (actual)
364
Serious AEs
3.9%
Results posted
Apr 2022
Primary outcomePrimary: Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use — 0.28 Pregnancies per 100 women years
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Pregnancies Per 100 Women Years (Pearl Index [PI]) Within Years 6 Thru 8 of Mirena Use |
0.28 | — |
| SECONDARY Menstrual Blood Loss (MBL) During a 30-day Period Starting at the Baseline Visit and at the End of Years 6, 7 and 8 |
0.000; 0.000; 0.000; 0.000 | — |
| SECONDARY Number of Participants With Menstrual Blood Loss (MBL) (>= 80 ml Per 30 Days) at End of Year 6, 7 and 8 of Mirena Use |
0; 0; 0 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
249; 14 | — |
Eligibility Criteria
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
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)
Data sourced from ClinicalTrials.gov (NCT02985541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.