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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, Davis
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
Mitchell Creinin, MD, University of California, Davis
ClinicalTrials.gov Identifier:
NCT01963403
First received: October 10, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention Phase
Abnormal Uterine Bleeding, Unspecified
Uterine Bleeding Heavy
Drug: EE 30mcg/LNG 150mcg
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 130
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)
Arms Assigned Interventions
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)
Other Names:
  • Levlen28
  • Levora
  • Portia 28
  • Altavera
Placebo Comparator: Placebo
Placebo
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963403

Contacts
Contact: Sarah Steimer 916-734-6846 sarah.steimer@ucdmc.ucdavis.edu

Locations
United States, California
University of California, Davis Department of Obstetrics and Gynecology Recruiting
Sacramento, California, United States, 95817
Contact: Sarah Steimer    916-734-6886    sarah.steimer@ucdmc.ucdavis.edu   
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    maddipatir@wudosis.wustl.edu   
Principal Investigator: Colleen McNicholas, MD         
Sponsors and Collaborators
University of California, Davis
Washington University School of Medicine
Investigators
Principal Investigator: Mitchell Creinin, MD University of California, Davis
Study Director: Melody Hou, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Mitchell Creinin, MD, Professor and Department Chair, University of California, Davis
ClinicalTrials.gov Identifier: NCT01963403     History of Changes
Other Study ID Numbers: UCD IRB Protocol Number 478388, MISP 50618
Study First Received: October 10, 2013
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
etonogestrel implant
birth control
irregular bleeding
heavy bleeding

Additional relevant MeSH terms:
Uterine Hemorrhage
Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on October 16, 2014