Menorrhagia Clinical Trial
Official title:
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Verified date | May 2019 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | January 8, 2018 |
Est. primary completion date | January 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 45 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Center For Women's Health | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total Number of Bleeding/Spotting Episodes | 60 days after initiation of study drug | ||
Other | Number of Prolonged Bleeding Episodes (>8 Days) | 60 days after initiation of study drug | ||
Other | Longest Bleed-free Interval | 60 days after initiation of study drug | ||
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Adverse Events | Descriptive reporting of adverse events for each arm | 30 days after initiation of study drug |
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