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Completed

NCT Number: NCT02824224

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

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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Key information

Conditions

Menorrhagia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Medicated Intrauterine Devices Menstruation Disturbances Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

OHSU Center For Women's Health

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tamoxifen

Drug

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

Other names: Nolvadex

Placebo (for Tamoxifen)

Drug

Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Primary outcomes

  1. Number of Bleeding and Spotting Days

    Time frame: 30 days after initiation of study drug

    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

Secondary outcomes

  1. Bleeding Pattern Satisfaction

    Time frame: 30 days after initiation of study drug

    0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.

  2. IUD Satisfaction

    Time frame: 30 days after initiation of study drug

    0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.

  3. Adverse Events

    Time frame: 30 days after initiation of study drug

    Descriptive reporting of adverse events for each arm

Other outcomes

  1. Total Number of Bleeding/Spotting Episodes

    Time frame: 60 days after initiation of study drug

  2. Number of Prolonged Bleeding Episodes (>8 Days)

    Time frame: 60 days after initiation of study drug

  3. Longest Bleed-free Interval

    Time frame: 60 days after initiation of study drug

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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