Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

NCT ID: NCT02903121

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2019-06-05

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).

Conditions

Bleeding; Implants; Breakthrough Bleeding

Study Design

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

Study Groups

Tamoxifen

Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study

Tamoxifen (open label)

Intervention Type: DRUG

Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study

Placebo

Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study

Interventions

Tamoxifen

Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study

Intervention Type: DRUG

Placebo

Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study

Intervention Type: DRUG

Tamoxifen (open label)

Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study

Intervention Type: DRUG

Other Intervention Names

Nolvadex; Genox; Tamifen; Nolvadex; Genox; Tamifen

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Alison Edelman

Professor, OB/GYN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

OHSU

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32649493 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

OHSU IRB 16519

Identifier Type: -

Identifier Source: org_study_id