Abnormal Uterine Bleeding, UnspecifiedPhase 4ROBINCT01963403
Treatment of Unacceptable Bleeding Patterns in ETG Implant Users With an Oral Contraceptive
A Phase 4 study testing EE 30mcg/LNG 150mcg in people with Abnormal Uterine Bleeding, Unspecified and Uterine Bleeding Heavy, run by University of California, Davis at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Unspecified, Uterine Bleeding Heavy
- What is being tested?
- EE 30mcg/LNG 150mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Davis Department of Obstetrics and Gynecology
Sacramento, California, 95817
Washington University School of Medicine, Department of Obstetrics and Gynecology
St Louis, Missouri, 63110
About this study
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
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
Read the 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.
- Being tested
- EE 30mcg/LNG 150mcg, Placebo
- Keywords
- etonogestrel implant, birth control, irregular bleeding, heavy bleeding
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EE 30mcg/LNG 150mcgDrug
Also called Levlen28, Levora, Portia 28, Altavera
1 pill per day; daily during study participation (up to 84 days)
PlaceboDrug
1 pill per day; daily during study participation (up to 84 days)
| Study group | Role | What they receive |
|---|---|---|
| EE 30mcg/LNG 150mcg | Active comparator | combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) Receives: Drug: EE 30mcg/LNG 150mcg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Bleeding improvement will be evaluated during first cycle of study treatment (28 days)
Secondary outcomes (1)
Number of Participants With Adverse Events
Participants will be evaluated for adverse events while using a combined oral contraceptive with ETG implant.
Measured: Adverse events will be evaluated at each contact (visits at 1 and 3 months, phone contact at 2 months) with the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2015
- Study completionSep 2015
Why it stopped: Futility of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abnormal Uterine Bleeding, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Mitchell Creinin, MD, University of California, Davis
- Investigators
- Mitchell Creinin, MD, Principal investigator, University of California, DavisMelody Hou, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963403
- Sponsor's protocol ID
- 478388
- Other IDs
- MISP 50618
- Acronym
- ROBI
- Status last verified
- Apr 2017
- First submitted
- 10 Oct 2013
- Last updated
- 12 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27419258
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01963403
- Acronym / sponsor ID
- ROBI / 478388
- Keywords
- etonogestrel implant, birth control, irregular bleeding, heavy bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility of recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Dec 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EE 30mcg/LNG 150mcg | Active comparator | Drug: EE 30mcg/LNG 150mcgcombined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EE 30mcg/LNG 150mcgAlso: Levlen28, Levora, Portia 28, Altavera1 pill per day; daily during study participation (up to 84 days) | Drug | EE 30mcg/LNG 150mcg |
| Placebo1 pill per day; daily during study participation (up to 84 days) | Drug | Placebo |
Primary outcome
Number of Participants With Bleeding Improvement
Time frame: Bleeding improvement will be evaluated during first cycle of study treatment (28 days)
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.
1 secondary outcome
Number of Participants With 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27419258Hou 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.
- Individual participant dataSharing planned: No
Related trials for Abnormal Uterine Bleeding, Unspecified
Not yet recruitingPhase 4
Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy
Minimally Invasive Surgical Procedures, Abnormal Uterine Bleeding, Unspecified
RecruitingObservational study
Assessment of Female Sexual Function Index (FSFI) Scores at 1 Month After Endometrial Sampling Performed Under Sedo-Analgesia or Local Anesthesia
Female Sexual Dysfunction, Endometrial Sampling
Active, not recruitingObservational study
The Learning Curve of a Gynecology and Obstetrics Resident Performing Vaginal Natural Orifice Transluminal Endoscopic Surgery (V-NOTES) Hysterectomy in a University Hospital
Abnormal Uterine Bleeding, Unspecified, Benign Gynecological Disease
Active, not recruitingObservational study
Evaluation of the Uterine Cavity in Perimenopausal Women.
Abnormal Uterine Bleeding, Unspecified
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Creinin, MD principal investigator
University of California, Davis
Melody Hou, MD study director
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EE 30mcg/LNG 150mcg in people with Abnormal Uterine Bleeding, Unspecified and Uterine Bleeding Heavy, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Bleeding Improvement (time frame: Bleeding improvement will be evaluated during first cycle of study treatment (28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.