Clinical trial NCT02824224: Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Official title: Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menorrhagia
Metrorrhagia
Medicated Intrauterine Devices
Keywords: levonorgestrel
breakthrough bleeding
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Number of Bleeding and Spotting Days
timeFrame: 30 days after initiation of study drug
Secondary outcomes:
measure: Bleeding Pattern Satisfaction
timeFrame: 30 days after initiation of study drug
measure: IUD Satisfaction
timeFrame: 30 days after initiation of study drug
measure: Adverse Events
timeFrame: 30 days after initiation of study drug
Other outcomes:
measure: Total Number of Bleeding/Spotting Episodes
timeFrame: 60 days after initiation of study drug
measure: Number of Prolonged Bleeding Episodes (>8 Days)
timeFrame: 60 days after initiation of study drug
measure: Longest Bleed-free Interval
timeFrame: 60 days after initiation of study drug
Locations:
city: Portland
country: United States
facility: OHSU Center For Women's Health
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Megan A Cohen, MD, MPH
role: STUDY_DIRECTOR
References:
citation: Cohen MA, Simmons KB, Edelman AB, Jensen JT. Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial. Contraception. 2019 Nov;100(5):391-396. doi: 10.1016/j.contraception.2019.06.009. Epub 2019 Jun 18.