Phase 4 N=56 Randomized Double-blind Treatment

Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

Menstruation Disturbances

Bottom Line

View on ClinicalTrials.gov: NCT02070692 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Bleeding Days — 65.6; 46.9 days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tamoxifen (Drug); Placebo (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Bleeding Days	65.6; 46.9	—
PRIMARY Bleeding/Spotting Days	10.5; 15.5	—
PRIMARY Consecutive Bleeding-free Days After Study Drug	28.8; 13.6	—
SECONDARY Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)	61.4; 53.6	—
SECONDARY Number of Participants Experiencing Ovulation After First Use of Study Drug	0; 0	—

Summary

The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.

Eligibility Criteria

Inclusion Criteria

Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month
Experiencing bleeding episodes more frequently than every 24 days, or a single episode of bleeding lasting longer than 14 days
English or Spanish speaking
Planning to continue implant use for six months
Access to a cell phone that can accept and send text messages

Exclusion Criteria

Postpartum within six months
Post-abortion within six weeks
Pregnant
Breast-feeding
Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
Bleeding dyscrasia
Anticoagulation use
Active cervicitis
Allergy to tamoxifen
History of venous thromboembolism
Current or past breast or uterine malignancy
Use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02070692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.