Phase 4
Completed N=37
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Menorrhagia · Metrorrhagia · Medicated Intrauterine Devices
Source: ClinicalTrials.gov NCT02824224 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Number of Bleeding and Spotting Days — 16.8; 12.0 days
◆ Published Evidence
Emerging
14citations · ~2 / year
Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial.
Summary
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.
Linked Publications
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Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Bleeding and Spotting Days |
16.8; 12.0 | — |
| SECONDARY Bleeding Pattern Satisfaction |
50.7; 58.6 | — |
| SECONDARY IUD Satisfaction |
82.7; 75.3 | — |
| SECONDARY Adverse Events |
12; 15 | — |
Eligibility Criteria
Inclusion Criteria
- initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
- access to reliable cell phone
- willing to receive and respond to daily text or email message to assess bleeding
Exclusion Criteria
- using IUD for indication other than contraception
- postpartum within 6 months, pregnant, or breastfeeding
- removal and replacement of IUD
- undiagnosed abnormal uterine bleeding prior to placement of IUD
- bleeding dyscrasia
- anti-coagulation use
- active cervicitis
- allergy to tamoxifen
- history of venous thromboembolism
- personal history of breast or uterine malignancy
- use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Data sourced from ClinicalTrials.gov (NCT02824224) and the linked publication. 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.