Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

NCT ID: NCT02070692

Last Updated: 2017-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Menstruation Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

7 day course of tamoxifen during an episode of irregular vaginal bleeding

Placebo

Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

7 day course of placebo during an episode of irregular vaginal bleeding

Interventions

Tamoxifen

7 day course of tamoxifen during an episode of irregular vaginal bleeding

Intervention Type: DRUG

Placebo

7 day course of placebo during an episode of irregular vaginal bleeding

Intervention Type: DRUG

Other Intervention Names

Nolvadex

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)

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Katharine Simmons, MD

Fellow in Family Planning

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Countries

United States

Other Identifiers

SFPRF14-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SFPRF14-1

Identifier Type: -

Identifier Source: org_study_id