Clinical trial NCT02903121: Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Official title: Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Implants
Breakthrough Bleeding
Keywords: Unscheduled bleeding
Long acting contraception
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-09-16
Enrollment: 109
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators will perform a 2 phase trial for treatment of women experiencing frequent or prolonged bleeding while using the ENG contraceptive implant. The first phase will consist of a randomized, controlled, double blind placebo-controlled clinical trial over a 90-day reference period and the second phase will allow both study arms to receive open-label treatment over an additional 90-day reference period. The primary outcome of the study will be the total number of consecutive bleeding-free days in first 30 days from Day 1 of first treatment (TX1).

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).

Primary outcomes:
measure: Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)
timeFrame: Day 1 to Day 30
Secondary outcomes:
measure: Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.
timeFrame: Day 1 to Day 90
Other outcomes:
measure: Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90
timeFrame: Day 1 of treatment number 4 to Day 90 (second 90 day reference period)
measure: Patient Satisfaction With Bleeding Pattern
timeFrame: Day 1 of treatment 1 to day 180
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
Study officials:
References:
citation: Edelman AB, Kaneshiro B, Simmons KB, Hauschildt JL, Bond K, Boniface ER, Jensen JT. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):323-332. doi: 10.1097/AOG.0000000000003896.