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Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users (Tamoxifen/BTB)

Primary Purpose

Bleeding, Implants, Breakthrough Bleeding

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tamoxifen
Placebo
Tamoxifen (open label)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bleeding focused on measuring Unscheduled bleeding, Long acting contraception

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

  • OHSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamoxifen

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2016
Last Updated
July 6, 2020
Sponsor
Oregon Health and Science University
Collaborators
Merck Women's Health Investigator Initiated Studies Program
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1. Study Identification

Unique Protocol Identification Number
NCT02903121
Brief Title
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Acronym
Tamoxifen/BTB
Official Title
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
June 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Merck Women's Health Investigator Initiated Studies Program

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Implants, Breakthrough Bleeding
Keywords
Unscheduled bleeding, Long acting contraception

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Experimental
Arm Description
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Nolvadex, Genox, Tamifen
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
Tamoxifen (open label)
Other Intervention Name(s)
Nolvadex, Genox, Tamifen
Intervention Description
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
Primary Outcome Measure Information:
Title
Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)
Description
Bleeding free days in the first 30 days
Time Frame
Day 1 to Day 30
Secondary Outcome Measure Information:
Title
Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.
Description
bleeding free days in the first 90 days
Time Frame
Day 1 to Day 90
Other Pre-specified Outcome Measures:
Title
Total Number of Bleeding Free Days Over the Second 90 Day Reference Period From Day 1 of Treatment Number 4 to Day 90
Description
bleeding free days in the second 90 days
Time Frame
Day 1 of treatment number 4 to Day 90 (second 90 day reference period)
Title
Patient Satisfaction With Bleeding Pattern
Description
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.
Time Frame
Day 1 of treatment 1 to day 180

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32649493
Citation
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.
Results Reference
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Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users

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