Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive (ROBI)
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
Abnormal Uterine Bleeding, Unspecified
Uterine Bleeding Heavy
Drug: EE 30mcg/LNG 150mcg
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Bleeding Improvement [ Time Frame: Bleeding improvement will be evaluated during first cycle of study treatment (28 days) ] [ Designated as safety issue: No ]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.
- Adverse Events [ Time Frame: Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant ] [ Designated as safety issue: Yes ]Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.
- Treatment Success or Failure [ Time Frame: Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months ] [ Designated as safety issue: No ]
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
- Bleeding patterns [ Time Frame: Evaluated at follow up visits at 1 month and, if subject continues after 1st month, again at 3 months ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: EE 30mcg/LNG 150mcg
combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)
Drug: EE 30mcg/LNG 150mcg
1 pill per day; daily during study participation (up to 84 days)
Placebo Comparator: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01963403
|Contact: Sarah Steimerfirstname.lastname@example.org|
|United States, California|
|University of California, Davis Department of Obstetrics and Gynecology||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Sarah Steimer 916-734-6886 email@example.com|
|Principal Investigator: Mitchell Creinin, MD|
|United States, Missouri|
|Washington University School of Medicine, Department of Obstetrics and Gynecology||Not yet recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Ragini Maddipati, MSW 314-747-6418 firstname.lastname@example.org|
|Principal Investigator: Colleen McNicholas, MD|
|Principal Investigator:||Mitchell Creinin, MD||University of California, Davis|
|Study Director:||Melody Hou, MD||University of California, Davis|