BleedingPhase 4NCT04205929
Use of Curcumin to Treat Unfavorable Bleeding Patterns in Contraceptive Implant Users
A Phase 4 study testing Curcumin in people with Bleeding and Implants, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant. 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?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 1 Aug 2023
- 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 speaking
- Women 15-45 years of age
- Currently using the ENG implant for at least 30 days and use proven on exam (palpation of implant at screening visit)
- Willing to continue using the implant for at least 30 days from study enrollment
- >7 days of continuous bleeding/spotting in the last 30 days, OR 2 or more episodes of bleeding/spotting in the last 30 days.
- Access to a reliable cell phone and must be willing to receive and respond to a daily text or email message to assess bleeding and use of study drug
- Negative gonorrhea/chlamydia screening performed at screening visit
Who cannot join
- Postpartum within six months
- Post-abortion within six weeks
- Currently pregnant
- Currently breast-feeding (to be eligible, must be 4-6 weeks from cessation of breastfeeding)
- Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant
- Bleeding dyscrasia
Show all 15Show fewer
- Anticoagulation use
- Active cervicitis
- Allergy to curcumin or turmeric
- History of venous thromboembolism
- Current or past breast or uterine malignancy
- Use of P450 pathway inducing drug
- Implant is due to be switched out in 2 months or less from enrollment
- Currently using oral contraceptives in addition to implant (to be eligible, needs to have a 4-6 week washout period)
- Prior pregnancy occurred while Nexplanon/Implanon was in place
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: a Randomized Clinical Trial of Curcumin
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
Read the detailed description
The investigators are proposing a randomized, double blind placebo-controlled clinical trial over a 30-day reference period for treatment of women experiencing bothersome bleeding while using the etonogestrel (ENG) contraceptive implant. The primary outcome of the study will be the total number of amenorrhea days in a 30-day reference period. The study has a number of secondary outcomes (see study objectives) focused around the efficacy of oral curcumin to stop bleeding/spotting and for how long.
- Conditions
- Bleeding, Implants, Breakthrough Bleeding
- Being tested
- Placebo, Curcumin
- Keywords
- Contraceptive implant, Irregular bleeding
- Medical subject headings
- Hemorrhage, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
CurcuminDrug
Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Placebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Receives: Drug: Placebo |
| Curcumin group | Experimental | Curcumin 600 mg (oral) once daily for 30 days to be started following 3 consecutive days of bleeding Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Days Without Bleeding or Spotting
Total number of days without bleeding or spotting in the 30-day reference period
Measured: Day 1 to Day 30
Secondary outcomes (3)
Total Number of Bleeding/Spotting Days
Total number of days with bleeding or spotting in the 30-day reference period
Measured: Day 1 to Day 30
Total Number of Spotting Days
Total number of days with spotting in the 30-day reference period
Measured: Day 1 to Day 30
Total Number of Bleeding Days
Total number of days with bleeding in the 30-day reference period
Measured: Day 1 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start15 Apr 2020
- Primary completion5 Nov 2022
- Study completion1 Aug 2023
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 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
- NCT04205929
- Sponsor's protocol ID
- OHSU IRB 20645
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2019
- Last updated
- 3 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edelman A, Boniface E, Schrote K, Messerle-Forbes M, O'Donnell A, Jensen JT, Han L. Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin. Am J Obstet Gynecol. 2023 Aug;229(2):145.e1-145.e9. doi: 10.1016/j.ajog.2023.04.028. Epub 2023 Apr 26.
PubMed 37116825
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: a Randomized Clinical Trial of Curcumin
- ClinicalTrials.gov ID
- NCT04205929
- Acronym / sponsor ID
- OHSU IRB 20645
- Conditions
- Bleeding, Implants, Breakthrough Bleeding
- Keywords
- Contraceptive implant, Irregular bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 3 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to study the effects of curcumin, the active ingredient in the spice turmeric, on the irregular bleeding experienced by women who use the contraceptive implant.
Detailed description
The investigators are proposing a randomized, double blind placebo-controlled clinical trial over a 30-day reference period for treatment of women experiencing bothersome bleeding while using the etonogestrel (ENG) contraceptive implant. The primary outcome of the study will be the total number of amenorrhea days in a 30-day reference period. The study has a number of secondary outcomes (see study objectives) focused around the efficacy of oral curcumin to stop bleeding/spotting and for how long.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo (oral) once daily for 30 days to be started following 3 consecutive days of bleeding |
| Curcumin group | Experimental | Drug: CurcuminCurcumin 600 mg (oral) once daily for 30 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 (7 listed)
- English speaking
- Women 15-45 years of age
- Currently using the ENG implant for at least 30 days and use proven on exam (palpation of implant at screening visit)
- Willing to continue using the implant for at least 30 days from study enrollment
- >7 days of continuous bleeding/spotting in the last 30 days, OR 2 or more episodes of bleeding/spotting in the last 30 days.
Key exclusion criteria (15 listed)
- Postpartum within six months
- Post-abortion within six weeks
- Currently pregnant
- Currently breast-feeding (to be eligible, must be 4-6 weeks from cessation of breastfeeding)
- 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 |
|---|---|---|
| PlaceboPlacebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding | Drug | Placebo group |
| CurcuminCurcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding | Drug | Curcumin group |
Primary outcome
Total Number of Days Without Bleeding or Spotting
Time frame: Day 1 to Day 30
Total number of days without bleeding or spotting in the 30-day reference period
3 secondary outcomes
Total Number of Bleeding/Spotting Days
Time frame: Day 1 to Day 30
Total Number of Spotting Days
Time frame: Day 1 to Day 30
Total Number of Bleeding Days
Time frame: Day 1 to Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37116825Edelman A, Boniface E, Schrote K, Messerle-Forbes M, O'Donnell A, Jensen JT, Han L. Treatment of unfavorable bleeding patterns in contraceptive implant users: a randomized clinical trial of curcumin. Am J Obstet Gynecol. 2023 Aug;229(2):145.e1-145.e9. doi: 10.1016/j.ajog.2023.04.028. Epub 2023 Apr 26.
- 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 Curcumin 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 7 inclusion and 15 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 3 Jul 2024. 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 3 Jul 2024). 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 Days Without Bleeding or Spotting (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 NCT04205929, 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 3 Jul 2024.