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

Menorrhagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824224
• Other study ID #: STUDY00015881
• Status: Completed
• Phase: Phase 4
• Start date: September 6, 2016
• Est. completion date: January 8, 2018

Study information

• Verified date: May 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Hemorrhage
• Medicated Intrauterine Devices
• Menorrhagia
• Metrorrhagia

Intervention

Drug:
• Tamoxifen
10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course
• Placebo (for Tamoxifen)
Sugar pill manufactured to mimic the tamoxifen 10mg tablet

Locations

Country	Name	City	State
United States	OHSU Center For Women's Health	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

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