Clinical trial NCT02070692: Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
Official title: Tamoxifen for the Treatment of Unfavorable Bleeding Patterns in Etonogestrel Contraceptive Implant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menstruation Disturbances
Keywords: Contraceptive implant
Irregular vaginal bleeding
Etonogestrel implant
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2014-02-25
Enrollment: 56
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG 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)

Primary outcomes:
measure: Bleeding Days
timeFrame: 180 days
measure: Bleeding/Spotting Days
timeFrame: 30 days
measure: Consecutive Bleeding-free Days After Study Drug
timeFrame: up to 180 days
Secondary outcomes:
measure: Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)
timeFrame: 180 days
measure: Number of Participants Experiencing Ovulation After First Use of Study Drug
timeFrame: 30 days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University (OHSU)
state: Oregon
Study officials:
References: