- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02070692
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
June 13, 2017 updated by: Katharine Simmons, MD, Oregon Health and Science University
Tamoxifen for the Treatment of Unfavorable Bleeding Patterns in Etonogestrel Contraceptive Implant Users
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University (OHSU)
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 43 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tamoxifen
Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.
|
7 day course of tamoxifen during an episode of irregular vaginal bleeding
Other Names:
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Placebo Comparator: Placebo
Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
|
7 day course of placebo during an episode of irregular vaginal bleeding
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding Days
Time Frame: 180 days
|
The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.
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180 days
|
Bleeding/Spotting Days
Time Frame: 30 days
|
Bleeding/spotting days
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30 days
|
Consecutive Bleeding-free Days After Study Drug
Time Frame: up to 180 days
|
Consecutive bleeding-free days after study drug
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up to 180 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)
Time Frame: 180 days
|
Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.
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180 days
|
Number of Participants Experiencing Ovulation After First Use of Study Drug
Time Frame: 30 days
|
A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users.
Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women.
Therefore, it is unlikely to interact with the ovulation suppression provided by the implant.
However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.
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30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 21, 2014
First Submitted That Met QC Criteria
February 21, 2014
First Posted (Estimate)
February 25, 2014
Study Record Updates
Last Update Posted (Actual)
July 2, 2017
Last Update Submitted That Met QC Criteria
June 13, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Menstruation Disturbances
- Hemorrhage
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
Other Study ID Numbers
- SFPRF14-1 (Other Grant/Funding Number: Society of Family Planning)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Study under review for publication
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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