OHSU

IRB #

IRB00010228

Title

Tamoxifen for the treatment of unfavorable bleeding patterns in Etonogestrel contraceptive implant users

Principal Investigator

Katharine Simmons

Study Purpose

The purpose of this study is to learn whether a medication called tamoxifen might help to stop or reduce reduce vaginal bleeding in women who use the contraceptive implant (Nexplanon or Implanon)

There are currently no medications approved to treat vaginal bleeding in women using the contraceptive implant. The study drug may reduce bleeding when taken for only a few days per month.

Right now, tamoxifen is not approved to treat bleeding in the United States because we do not know if it works. Tamoxifen is currently approved in the United States for treatment of some breast cancers. Women using it for breast cancer take tamoxifen for five years. In this study you will use tamoxifen for only one week at a time. The study drug comes in a bottle of 14 pills. It is taken as one pill twice daily for seven days. Each pack of 14 pills is considered a “use” of study drug.

Medical Condition(s)

Eligibility Criteria

•Between 15 and 45 years old
•Currently using the contraceptive implant for birth control (Nexplanon, Implanon).
•Experiencing too much bleeding while using the implant

Age Range

15 - 45

Healthy Volunteers Needed

No

Duration of Participation

6 months

Minors Included

No

Contact

Women's Health Research Unit
503-494-3666
whru@ohsu.edu

Sponsor

Society of Family Planning

Recruitment End

06/04/2016

Compensation Provided

Yes

Compensation

You will receive $25 in cash at each study visit. This is a total of $175 for completing all study visits. You will receive an extra $25 in cash when you complete and return all 14 urine samples. If you complete all study procedures, you will have received a total of $200.


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