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Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive (ROBI)

Primary Purpose

Abnormal Uterine Bleeding, Unspecified, Uterine Bleeding Heavy

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EE 30mcg/LNG 150mcg
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding, Unspecified focused on measuring etonogestrel implant, birth control, irregular bleeding, heavy bleeding

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who have an ETG implant in place
  • Women who subjectively experience the side effect of an undesirable bleeding profile such as bleeding irregularity or heavy flow after ETG implant was placed and who desire intervention for this side effect by either treatment of bleeding or removal of the implant
  • Age 14 years an older, inclusive

Exclusion Criteria:

  • Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids, cervical polyp, or other organic cause of bleeding)
  • Has attempted prescription treatment for menstrual side effects while using ETG implant

  • Has one or more of the conditions considered Category 3 (risks outweigh benefits) or Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use:

    • Current or history of heart or vascular diseases, including deep venous thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum cardiomyopathy, and complicated valvular heart disease
    • Hypertension, even if adequately controlled
    • Diabetes with vascular involvement
    • Headaches with focal aura, or migraines in women age 35 and older even without focal aura
    • Major surgery with prolonged immobilization
    • Breast cancer (current or past)
    • Severe (decompensated) cirrhosis
    • Acute or flare viral hepatitis
    • Breastfeeding less than 1 month postpartum
    • Post-partum less than 3 weeks
    • 35 years of age and older and smoking
    • Multiple risk factors for arterial cardiovascular disease
    • Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies
    • Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use
    • On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine)
    • On Ritonavir-boosted protease inhibitors for antiretroviral therapy
  • Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study

Sites / Locations

  • University of California, Davis Department of Obstetrics and Gynecology
  • Washington University School of Medicine, Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EE 30mcg/LNG 150mcg

Placebo

Arm Description

combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)

Placebo

Outcomes

Primary Outcome Measures

Number of Participants With Bleeding Improvement
Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.

Secondary Outcome Measures

Number of Participants With Adverse Events
Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.

Full Information

First Posted
October 10, 2013
Last Updated
April 4, 2017
Sponsor
University of California, Davis
Collaborators
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01963403
Brief Title
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
Acronym
ROBI
Official Title
Relief of Bleeding on the Implant: Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With a Combined Oral Contraceptive: A Placebo-Controlled Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Futility of recruitment
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Davis
Collaborators
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This double-blinded, placebo-controlled, randomized trial will compare the effects of the use of a combined oral contraceptive pill to a placebo pill for women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant. The hypothesis of the study is: Use of combined oral contraceptive will significantly improve bleeding patterns for users of ETG implant Continuation rate of ETG implant users will be increased by use of combined oral contraceptive in women desiring ETG implant removal because of the undesirable bleeding Adverse events will be uncommon and acceptable to women who use a combined oral contraceptive with the ETG implant
Detailed Description
Women who are experiencing irregular and/or heavy bleeding associated with the use of an etonogestrel (ETG) implant will be recruited for this study. Women who have bothersome bleeding will be randomized to use either a combined oral contraceptive pill or a placebo pill. Participants will take one pill every day and record their bleeding patterns on a daily diary. Participants will have one screening/enrollment visit, two in-person follow up visits, and one telephone follow up contact. Subjects will be enrolled for a total of 84 days (three months). Participants will be assigned to a treatment group at her screening/enrollment visit. Her first follow up visit will occur 22-28 days after her enrollment. Participants can choose to: Continue use of assigned treatment medication Discontinue use of assigned treatment medication, but use an open-label combined oral contraceptive pill Discontinue the use of assigned treatment medication, decline use of an open-label combined oral contraceptive pill Discontinue use of ETG implant. Participants who choose to continue use of ETG implant will have a follow up telephone contact 50-56 days after her enrollment visit. A final in-person visit will occur 78-84 days after enrollment. Bleeding patterns will be assessed by daily bleeding diaries completed by the participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding, Unspecified, Uterine Bleeding Heavy
Keywords
etonogestrel implant, birth control, irregular bleeding, heavy bleeding

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
EE 30mcg/LNG 150mcg
Arm Type
Active Comparator
Arm Description
combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
EE 30mcg/LNG 150mcg
Other Intervention Name(s)
Levlen28, Levora, Portia 28, Altavera
Intervention Description
1 pill per day; daily during study participation (up to 84 days)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 pill per day; daily during study participation (up to 84 days)
Primary Outcome Measure Information:
Title
Number of Participants With Bleeding Improvement
Description
Bleeding improvement will be measured by participant response to the question of whether she feels her bleeding is improved and she is satisfied with the treatment.
Time Frame
Bleeding improvement will be evaluated during first cycle of study treatment (28 days)
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.
Time Frame
Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant
Other Pre-specified Outcome Measures:
Title
Number of Participants withTreatment Success or Failure
Description
Treatment success will be measured by desire to continue treatment because the initial treatment made the bleeding better. Partial failure of the study treatment will be measured by the desire to continue treatment because the initial treatment did not work Complete failure of treatment will be measured by the desire to: discontinue treatment because it did not work; no further treatment requested ETG implant removal Desire to use non-study treatment
Time Frame
Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months
Title
Bleeding Patterns and Number of Participants With Bleeding Improvement
Description
Bleeding improvement in women who received placebo but opted for open-label treatment after first cycle Bleeding improvement over the 84 days of study participation Bleeding patterns in placebo vs. combined oral contraceptive users
Time Frame
Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who have an ETG implant in place Women who subjectively experience the side effect of an undesirable bleeding profile such as bleeding irregularity or heavy flow after ETG implant was placed and who desire intervention for this side effect by either treatment of bleeding or removal of the implant Age 14 years an older, inclusive Exclusion Criteria: Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids, cervical polyp, or other organic cause of bleeding) Has attempted prescription treatment for menstrual side effects while using ETG implant Has one or more of the conditions considered Category 3 (risks outweigh benefits) or Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use: Current or history of heart or vascular diseases, including deep venous thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum cardiomyopathy, and complicated valvular heart disease Hypertension, even if adequately controlled Diabetes with vascular involvement Headaches with focal aura, or migraines in women age 35 and older even without focal aura Major surgery with prolonged immobilization Breast cancer (current or past) Severe (decompensated) cirrhosis Acute or flare viral hepatitis Breastfeeding less than 1 month postpartum Post-partum less than 3 weeks 35 years of age and older and smoking Multiple risk factors for arterial cardiovascular disease Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine) On Ritonavir-boosted protease inhibitors for antiretroviral therapy Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Creinin, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melody Hou, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
Facility Information:
Facility Name
University of California, Davis Department of Obstetrics and Gynecology
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Washington University School of Medicine, Department of Obstetrics and Gynecology
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27419258
Citation
Hou MY, McNicholas C, Creinin MD. Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2016 Oct;21(5):361-6. doi: 10.1080/13625187.2016.1210122. Epub 2016 Jul 15.
Results Reference
result

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Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive

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