MenorrhagiaPhase 4NCT02824224
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
A Phase 4 study testing Tamoxifen in people with Menorrhagia and Metrorrhagia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course… 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
- Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices
- What is being tested?
- Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2016to 8 Jan 2018
- 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
- initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
- access to reliable cell phone
- willing to receive and respond to daily text or email message to assess bleeding
Who cannot join
- using IUD for indication other than contraception
- postpartum within 6 months, pregnant, or breastfeeding
- removal and replacement of IUD
- undiagnosed abnormal uterine bleeding prior to placement of IUD
- bleeding dyscrasia
- anti-coagulation use
Show all 11Show fewer
- active cervicitis
- allergy to tamoxifen
- history of venous thromboembolism
- personal history of breast or uterine malignancy
- use of medication contraindicated with use of tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Center For Women's Health
Portland, Oregon, 97239
About this study
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.
Read the detailed description
New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.
- Conditions
- Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices
- Being tested
- Tamoxifen, Placebo (for Tamoxifen)
- Keywords
- levonorgestrel, breakthrough bleeding
- Medical subject headings
- Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Nolvadex
10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course
Placebo (for Tamoxifen)Drug
Sugar pill manufactured to mimic the tamoxifen 10mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Tamoxifen 10mg tablet by mouth twice daily for 7 days Receives: Drug: Tamoxifen |
| Placebo | Placebo comparator | Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days Receives: Drug: Placebo (for Tamoxifen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Bleeding and Spotting Days
Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group
Measured: 30 days after initiation of study drug
Secondary outcomes (3)
Bleeding Pattern Satisfaction
0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with bleeding pattern. 0 mm = not at all satisfied, 100 mm = very satisfied.
Measured: 30 days after initiation of study drug
IUD Satisfaction
0-100 mm Visual Analog Scale (VAS) measurement of satisfaction with IUD (intrauterine device). 0 mm = not at all satisfied, 100 mm = very satisfied.
Measured: 30 days after initiation of study drug
Adverse Events
Descriptive reporting of adverse events for each arm
Measured: 30 days after initiation of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start6 Sep 2016
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
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 MenorrhagiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Jensen, Oregon Health and Science University
- Investigators
- Megan A Cohen, MD, MPH, Study director, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824224
- Sponsor's protocol ID
- STUDY00015881
- Status last verified
- May 2019
- First submitted
- 2 Jul 2016
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cohen MA, Simmons KB, Edelman AB, Jensen JT. Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial. Contraception. 2019 Nov;100(5):391-396. doi: 10.1016/j.contraception.2019.06.009. Epub 2019 Jun 18.
PubMed 31226322
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
- ClinicalTrials.gov ID
- NCT02824224
- Acronym / sponsor ID
- STUDY00015881
- Conditions
- Menorrhagia, Metrorrhagia, Medicated Intrauterine Devices
- Keywords
- levonorgestrel, breakthrough bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 21 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of participants will receive a course of tamoxifen three weeks after insertion of the IUD, while the other half of participants will receive a course of placebo.
Detailed description
New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen 10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement of the IUD. Subjects will maintain a record of daily bleeding and spotting using an electronic text messaging diary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: TamoxifenTamoxifen 10mg tablet by mouth twice daily for 7 days |
| Placebo | Placebo comparator | Drug: Placebo (for Tamoxifen)Placebo tablet (for tamoxifen tablet) by mouth twice daily for 7 days |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- initiating use of 52mg levonorgestrel-releasing IUD for contraceptive purposes
- access to reliable cell phone
- willing to receive and respond to daily text or email message to assess bleeding
Key exclusion criteria (11 listed)
- using IUD for indication other than contraception
- postpartum within 6 months, pregnant, or breastfeeding
- removal and replacement of IUD
- undiagnosed abnormal uterine bleeding prior to placement of IUD
- bleeding dyscrasia
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: Nolvadex10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course | Drug | Tamoxifen |
| Placebo (for Tamoxifen)Sugar pill manufactured to mimic the tamoxifen 10mg tablet | Drug | Placebo |
Primary outcome
Number of Bleeding and Spotting Days
Time frame: 30 days after initiation of study drug
Mean number of bleeding and spotting days in the tamoxifen group compared to the mean number of bleeding and spotting days in the placebo group
3 secondary outcomes
Bleeding Pattern Satisfaction
Time frame: 30 days after initiation of study drug
IUD Satisfaction
Time frame: 30 days after initiation of study drug
Adverse Events
Time frame: 30 days after initiation of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31226322Cohen MA, Simmons KB, Edelman AB, Jensen JT. Tamoxifen for the prevention of unscheduled bleeding in new users of the levonorgestrel 52-mg intrauterine system: a randomized controlled trial. Contraception. 2019 Nov;100(5):391-396. doi: 10.1016/j.contraception.2019.06.009. Epub 2019 Jun 18.
- 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.
Megan A Cohen, MD, MPH study director
Oregon Health and Science University
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 in people with Menorrhagia and Metrorrhagia, 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 3 inclusion and 11 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 4 Jun 2019. 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 21 May 2019). 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 Bleeding and Spotting Days (time frame: 30 days after initiation of study drug). 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 NCT02824224, 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 4 Jun 2019.