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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-06

Study Completion Date

2018-01-08

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.

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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.

Conditions

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Menorrhagia Metrorrhagia Medicated Intrauterine Devices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tamoxifen

Tamoxifen 10mg tablet by mouth twice daily for 7 days

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Placebo

Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo (for Tamoxifen)

Intervention Type DRUG

Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Interventions

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Tamoxifen

10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course

Intervention Type DRUG

Placebo (for Tamoxifen)

Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Intervention Type DRUG

Other Intervention Names

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Nolvadex

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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes