Phase 4
Completed N=109
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Bleeding · Implants · Breakthrough Bleeding
Source: ClinicalTrials.gov NCT02903121 ↗
Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1) — 18.5; 8.7 days
◆ Published Evidence
Established
21citations · ~4 / year
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial.
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.
Linked Publications
-
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial.
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 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02903121) and the linked publication. 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. Informational only — not medical advice.