Phase 4 N=109 Randomized Quadruple-blind Treatment

Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Bleeding · Implants · Breakthrough Bleeding

Bottom Line

View on ClinicalTrials.gov: NCT02903121 ↗

Enrolled (actual)

109

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1) — 18.5; 8.7 days

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tamoxifen (Drug); Placebo (Drug); Tamoxifen (open label) (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Oregon Health and Science University
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)	18.5; 8.7	—
SECONDARY Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.	60; 52	—

Summary

The etonogestrel (ENG) subdermal contraceptive implant (ENG implant) is a highly effective method of preventing pregnancy, but it has bleeding side effects that make it unappealing for many women. The only study to demonstrate a sustained reduction in bleeding lasting for two months was the selective estrogen receptor modulator (SERM) tamoxifen in users of the levonogestrel (LNG) contraceptive implant. Based on the investigators encouraging preliminary data of tamoxifen and ENG implant users, the investigators plan to perform additional studies on the impact of tamoxifen on the breakthrough bleeding experience by ENG implant users.

Eligibility Criteria

Inclusion Criteria

English or Spanish speaking
women aged 15-45 years of age
Currently using the ENG-implant for at least 1 month and use proven on exam (palpation of implant at screening visit)
Willing to continue using the implant for at least 6 months
>7 days of continuous bleeding/spotting, or 2 or more episodes of bleeding/spotting in the last 30 days.
Cellphone that is able to receive and respond to a daily text or email message .

Exclusion Criteria

Postpartum within six months
post-abortion within six weeks
currently pregnant
currently 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 (NCT02903121). 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.