ContraceptionCALMNCT04725643
Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
An observational study of Contraception and Contraceptive Usage, run by University of California, San Diego at 1 site in United States.
Trial summary
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Contraceptive Usage, Family Planning
- What is being tested?
- Track bleeding patterns before and after implant
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients scheduled at UC San Diego for a contraceptive implant after approximately 3 years (32-40 months) of use.
Who may be able to join
- Reproductive aged women 18-50 years old
- With a contraceptive implant (for patient participants)
- Able to consent in English
- Palpable contraceptive implant
Who cannot join
- Non-palpable contraceptive implant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.
Read the detailed description
There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement.
The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys.
Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.
- Conditions
- Contraception, Contraceptive Usage, Family Planning
- Being tested
- Track bleeding patterns before and after implant
- Keywords
- Nexplanon, Contraceptive implant
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Track bleeding patterns before and after implantDevice
Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart. Participants will also complete weekly surveys regarding their satisfaction with their bleeding. We will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.
| Study group | Role | What they receive |
|---|---|---|
| Implant Group | Adults who are choosing to get a replacement Nexplanon and agree to track and report their bleeding patterns for one month before replacement and 3 months after. Receives: Device: Track bleeding patterns before and after implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of bleeding days during 4 weeks before replacement
Number of days participants experienced bleeding during the 4 weeks before implant replacement.
Measured: 4 weeks (28 days) before day of implant replacement.
Number of bleeding days 4 weeks after replacement
Number of days participants experienced bleeding during the 4 weeks after implant replacement.
Measured: 4 weeks (28 days) after day of implant replacement
Secondary outcomes (4)
Satisfaction with bleeding before replacement
Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding before implant replacement.
Measured: 4 weeks (28 days) before day of implant replacement
Satisfaction with bleeding after replacement
Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding after replacement
Measured: 4 weeks (28 days) after day of implant replacement
Number of bleeding days during the second month after implant replacement
Number of days participants experienced bleeding during the second month after implant replacement
Measured: Second month (defined as 29-56 days) after implant replacement
Number of bleeding days during the third month post replacement
Number of days participants experienced bleeding during the third month after implant replacement
Measured: Third month (defined as 57-84 days) after implant replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start17 Feb 2022
- Primary completion11 Jan 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Sheila Mody, University of California, San Diego
- Investigators
- Sheila Mody, MD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725643
- Sponsor's protocol ID
- 201908
- Acronym
- CALM
- Status last verified
- Jan 2024
- First submitted
- 16 Dec 2020
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.
PubMed 2400752
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On
- ClinicalTrials.gov ID
- NCT04725643
- Acronym / sponsor ID
- CALM / 201908
- Conditions
- Contraception, Contraceptive Usage, Family Planning
- Keywords
- Nexplanon, Contraceptive implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.
Detailed description
There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement.
The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys.
Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant Group | – | Device: Track bleeding patterns before and after implantAdults who are choosing to get a replacement Nexplanon and agree to track and report their bleeding patterns for one month before replacement and 3 months after. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients scheduled at UC San Diego for a contraceptive implant after approximately 3 years (32-40 months) of use.
Key inclusion criteria (4 listed)
- Reproductive aged women 18-50 years old
- With a contraceptive implant (for patient participants)
- Able to consent in English
- Palpable contraceptive implant
Key exclusion criteria (1 listed)
- Non-palpable 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 |
|---|---|---|
| Track bleeding patterns before and after implantParticipants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart. Participants will also complete weekly surveys regarding their satisfaction with their bleeding. We will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant. | Device | Implant Group |
Primary outcome
Number of bleeding days during 4 weeks before replacement
Time frame: 4 weeks (28 days) before day of implant replacement.
Number of days participants experienced bleeding during the 4 weeks before implant replacement.
Number of bleeding days 4 weeks after replacement
Time frame: 4 weeks (28 days) after day of implant replacement
Number of days participants experienced bleeding during the 4 weeks after implant replacement.
4 secondary outcomes
Satisfaction with bleeding before replacement
Time frame: 4 weeks (28 days) before day of implant replacement
Satisfaction with bleeding after replacement
Time frame: 4 weeks (28 days) after day of implant replacement
Number of bleeding days during the second month after implant replacement
Time frame: Second month (defined as 29-56 days) after implant replacement
Number of bleeding days during the third month post replacement
Time frame: Third month (defined as 57-84 days) after implant replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 2400752Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x.
- 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.
Sheila Mody, MD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Contraceptive Usage, run by University of California, San Diego 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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 days during 4 weeks before replacement (time frame: 4 weeks (28 days) before day of implant replacement.). The study lists 2 primary outcomes in all. 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 NCT04725643, 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 23 Jan 2024.