Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Study Overview
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Brief Summary
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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.

Detailed Description
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New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.

Official Title
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Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)

Conditions
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Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices

Intervention / Treatment
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* Drug: Tamoxifen
* Drug: Placebo (for Tamoxifen)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamoxifen<br>Tamoxifen 10mg tablet by mouth twice daily for 7 days | Drug: Tamoxifen<br>* 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course<br>* Other names: Nolvadex;|
| Placebo Comparator: Placebo<br>Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days | Drug: Placebo (for Tamoxifen)<br>* Sugar pill manufactured to mimic the tamoxifen 10mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Bleeding and Spotting Days | Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group | 30 days after initiation of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Pattern Satisfaction | 0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied. | 30 days after initiation of study drug | 
| IUD Satisfaction | 0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied. | 30 days after initiation of study drug | 
| Adverse Events | Descriptive reporting of adverse events for each arm | 30 days after initiation of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levonorgestrel, breakthrough bleeding