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Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

Primary Purpose

Menstruation Disturbances

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

About this trial

This is an interventional treatment trial for Menstruation Disturbances focused on measuring Contraceptive implant, Irregular vaginal bleeding, Etonogestrel implant

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • Oregon Health & Science University (OHSU)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tamoxifen

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
Bleeding/Spotting Days
Bleeding/spotting days
Consecutive Bleeding-free Days After Study Drug
Consecutive bleeding-free days after study drug

Secondary Outcome Measures

Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)
Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.
Number of Participants Experiencing Ovulation After First Use of Study Drug
A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.

Full Information

First Posted
February 21, 2014
Last Updated
June 13, 2017
Sponsor
Oregon Health and Science University
Collaborators
Society of Family Planning
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1. Study Identification

Unique Protocol Identification Number
NCT02070692
Brief Title
Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users
Official Title
Tamoxifen for the Treatment of Unfavorable Bleeding Patterns in Etonogestrel Contraceptive Implant Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Society of Family Planning

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menstruation Disturbances
Keywords
Contraceptive implant, Irregular vaginal bleeding, Etonogestrel implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tamoxifen
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Intervention Type
Drug
Intervention Name(s)
Tamoxifen
Other Intervention Name(s)
Nolvadex
Intervention Description
7 day course of tamoxifen during an episode of irregular vaginal bleeding
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
7 day course of placebo during an episode of irregular vaginal bleeding
Primary Outcome Measure Information:
Title
Bleeding Days
Description
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.
Time Frame
180 days
Title
Bleeding/Spotting Days
Description
Bleeding/spotting days
Time Frame
30 days
Title
Consecutive Bleeding-free Days After Study Drug
Description
Consecutive bleeding-free days after study drug
Time Frame
up to 180 days
Secondary Outcome Measure Information:
Title
Satisfaction (as Recorded on a 100mm Visual Analog Scale Where 0 is Not at All Satisfied and 100mm is Completely Satisfied)
Description
Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.
Time Frame
180 days
Title
Number of Participants Experiencing Ovulation After First Use of Study Drug
Description
A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Facility Information:
Facility Name
Oregon Health & Science University (OHSU)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study under review for publication

Learn more about this trial

Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

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