NCT02070692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

February 21, 2014

Results QC Date

April 3, 2017

Last Update Submit

June 13, 2017

Conditions

Menstruation Disturbances

Keywords

Contraceptive implantIrregular vaginal bleedingEtonogestrel implant

Outcome Measures

Primary Outcomes (3)

  • Bleeding Days

    The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.

    180 days

  • Bleeding/Spotting Days

    Bleeding/spotting days

    30 days

  • Consecutive Bleeding-free Days After Study Drug

    Consecutive bleeding-free days after study drug

    up to 180 days

Secondary Outcomes (2)

  • Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)

    180 days

  • Number of Participants Experiencing Ovulation After First Use of Study Drug

    30 days

Study Arms (2)

Tamoxifen

EXPERIMENTAL

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.

Drug: Tamoxifen

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

TamoxifenDRUG

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

Also known as: Nolvadex
Tamoxifen
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Menstruation Disturbances

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Katharine Simmons
Organization
Oregon Health & Science University
simmonka@ohsu.edu
404-718-6619

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow in Family Planning

Study Record Dates

First Submitted

February 21, 2014

First Posted

February 25, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 2, 2017

Results First Posted

June 14, 2017

Record last verified: 2017-06

Locations

US(1)