Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

NCT02903121 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: OHSU IRB 16519
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Implants; Breakthrough Bleeding

Keywords

Unscheduled bleeding; Long acting contraception

Outcome Measures

Primary Outcomes (1)

• Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)

  Bleeding free days in the first 30 days

  Day 1 to Day 30

Secondary Outcomes (1)

• Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.

  Day 1 to Day 90

Other Outcomes (2)

• Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90

  Day 1 of treatment number 4 to Day 90 (second 90 day reference period)

• Patient Satisfaction With Bleeding Pattern

  Day 1 of treatment 1 to day 180

Study Arms (2)

Tamoxifen

EXPERIMENTAL

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

Drug: Tamoxifen; Drug: Tamoxifen (open label)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tamoxifen 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

Also known as: Nolvadex, Genox, Tamifen

Tamoxifen

Placebo 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

Placebo

Tamoxifen (open label) 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

Also known as: Nolvadex, Genox, Tamifen

Tamoxifen

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 32649493 DERIVED

MeSH Terms

Conditions

Hemorrhage; Metrorrhagia

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Alison Edelman, MD, MPH
• Organization: Oregon Health and Science University

edelmana@ohsu.edu

5034943666

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, OB/GYN

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: January 20, 2017
• Primary Completion: June 5, 2019
• Study Completion: June 5, 2019
• Last Updated: July 15, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)