BleedingPhase 4Tamoxifen/BTBNCT02903121
Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
A Phase 4 study testing Tamoxifen and Tamoxifen (open label) in people with Bleeding and Implants, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Implants, Breakthrough Bleeding
- What is being tested?
- Tamoxifen and Tamoxifen (open label)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 5 Jun 2019
- 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 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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 .
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Bleeding, Implants, Breakthrough Bleeding
- Being tested
- Tamoxifen, Placebo, Tamoxifen (open label)
- Keywords
- Unscheduled bleeding, Long acting contraception
- Medical subject headings
- Hemorrhage, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Nolvadex, Genox, Tamifen
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
PlaceboDrug
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
Tamoxifen (open label)Drug
Also called Nolvadex, Genox, Tamifen
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
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding Receives: Drug: Tamoxifen; Drug: Tamoxifen (open label) |
| Placebo | Placebo comparator | Placebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Consecutive Bleeding-free Days in First 30 Days From Day 1 of First Treatment (TX1)
Bleeding free days in the first 30 days
Measured: Day 1 to Day 30
Secondary outcomes (1)
Total Number of Bleeding Free Days Over the First 90 Day Reference Period From Day 1 of Treatment 1.
bleeding free days in the first 90 days
Measured: Day 1 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start20 Jan 2017
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
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 BleedingStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Alison Edelman, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903121
- Sponsor's protocol ID
- OHSU IRB 16519
- Acronym
- Tamoxifen/BTB
- Status last verified
- Jul 2020
- First submitted
- 13 Sep 2016
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edelman AB, Kaneshiro B, Simmons KB, Hauschildt JL, Bond K, Boniface ER, Jensen JT. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):323-332. doi: 10.1097/AOG.0000000000003896.
PubMed 32649493
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users
- ClinicalTrials.gov ID
- NCT02903121
- Acronym / sponsor ID
- Tamoxifen/BTB / OHSU IRB 16519
- Conditions
- Bleeding, Implants, Breakthrough Bleeding
- Keywords
- Unscheduled bleeding, Long acting contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 |
|---|---|---|
| Tamoxifen | Experimental | Drug: Tamoxifen, Drug: Tamoxifen (open label)Tamoxifen 10 mg (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (oral) twice daily for 7 days to be started following 3 consecutive days of bleeding |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- Postpartum within six months
- post-abortion within six weeks
- currently pregnant
- currently breast-feeding
- undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
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 |
|---|---|---|
| TamoxifenAlso: Nolvadex, Genox, TamifenTamoxifen 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 | Drug | Tamoxifen |
| PlaceboPlacebo 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 | Drug | Placebo |
| Tamoxifen (open label)Also: Nolvadex, Genox, TamifenTamoxifen 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 | Drug | Tamoxifen |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32649493Edelman AB, Kaneshiro B, Simmons KB, Hauschildt JL, Bond K, Boniface ER, Jensen JT. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):323-332. doi: 10.1097/AOG.0000000000003896.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamoxifen and Tamoxifen (open label) in people with Bleeding and Implants, run by Oregon Health and Science University at 1 site 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 7 Jul 2020). 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?
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). 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 NCT02903121, 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 15 Jul 2020.