ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 826 for:    Recruiting, Not yet recruiting, Available Studies | Bleeding

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02903121
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Merck Women's Health Investigator Initiated Studies Program
Information provided by (Responsible Party):
Alison Edelman, Oregon Health and Science University

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.

Condition or disease Intervention/treatment Phase
Bleeding Implants Breakthrough Bleeding Drug: Tamoxifen Drug: Placebo Drug: Tamoxifen (open label) Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Tamoxifen
Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding
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
Other Names:
  • Nolvadex
  • Genox
  • Tamifen

Drug: 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
Other Names:
  • Nolvadex
  • Genox
  • Tamifen

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




Primary Outcome Measures :
  1. total number of consecutive bleeding-free days in first 30 days from Day 1 of first treatment (TX1) [ Time Frame: Day 1 to Day 30 ]
    Bleeding free days in the first 30 days


Secondary Outcome Measures :
  1. total number of bleeding free days over the first 90 day reference period from Day 1 of treatment 1. [ Time Frame: Day 1 to Day 90 ]
    bleeding free days in the first 90 days

  2. Total number of treatments taken during the first 90 day reference period [ Time Frame: Day 1 to day 90 ]
    Number of 7-day treatments taken in first 90 days (up to 6)

  3. Total number of treatments taken during the second 90 day reference period [ Time Frame: Day 1 to Day 90 (during second reference period) ]
    Number of 7-day treatments taken in second 90 days ( up to 6)


Other Outcome Measures:
  1. total number of bleeding free days over the second 90 day reference period from Day 1 of treatment number 4 to Day 90 [ Time Frame: Day 1 of treatment number 4 to Day 90 (second 90 day reference period) ]
    bleeding free days in the second 90 days

  2. Patient satisfaction with bleeding pattern [ Time Frame: Day 1 of treatment 1 to day 180 ]
    Patient satisfaction with bleeding pattern



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903121


Contacts
Contact: Women's Health Research Unit Department of OB/GYN 503-494-3666 whru@ohsu.edu

Locations
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Alison B Edelman, MD, MPH    503-494-5949    edelmana@ohsu.edu   
Principal Investigator: Alison B Edelman, MD, MPH         
Sponsors and Collaborators
Oregon Health and Science University
Merck Women's Health Investigator Initiated Studies Program

Responsible Party: Alison Edelman, Professor, OB/GYN, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02903121     History of Changes
Other Study ID Numbers: OHSU IRB 16519
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Alison Edelman, Oregon Health and Science University:
Unscheduled bleeding
Long acting contraception

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Tamoxifen
Reproductive Control Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents