Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Bleeding Clinical Trial

— Tamoxifen/BTB  

Official title:

Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903121
• Other study ID #: OHSU IRB 16519
• Status: Completed
• Phase: Phase 4
• Start date: January 20, 2017
• Est. completion date: June 5, 2019

Study information

• Verified date: July 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bleeding
• Breakthrough Bleeding
• Hemorrhage
• Implants
• Metrorrhagia

Intervention

Drug:
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Merck Women's Health Investigator Initiated Studies Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90	bleeding free days in the second 90 days	Day 1 of treatment number 4 to Day 90 (second 90 day reference period)
Other	Patient Satisfaction With Bleeding Pattern	Patient satisfaction with bleeding pattern. Assessed by visual analog scale to determine satisfaction with bleeding patterns on a scale of 0-100 mm, where 0 mm represents not satisfied at all and 100 mm is totally satisfied.	Day 1 of treatment 1 to day 180
Primary	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	Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.	bleeding free days in the first 90 days	Day 1 to Day 90