Vaginal BleedingNCT03074903
Does Skyla Insertion Timing Impact Bleeding?
An observational study of Vaginal Bleeding, run by Rutgers, The State University of New Jersey at 3 sites in United States.
Trial summary
Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Bleeding
- What is being tested?
- Intrauterine system
- Type of treatment
- Medical device
- How many people
- 132 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Apr 2016to 28 Jul 2017
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women presenting for intrauterine device insertion.
Who may be able to join
- Women aged 18-45
- Parous or nulliparous
- Desire Skyla for contraception
- Regular menstrual cycles (21-35 days)
- Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days
Who cannot join
- Vaginal or cesarean delivery in the past 12 weeks
- Abortion in the past 6 weeks
- Uterine anomaly distorting the uterus
- Acute pelvic inflammatory disease
- Uterine bleeding of unknown etiology
- Acute liver disease or tumor
- History of progestin-sensitive cancer
- Abnormal pap smear awaiting diagnostic or therapeutic intervention
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Planned Parenthood
Morristown, New Jersey, 07960
NJFPC
Newark, New Jersey, 07103
SHS
Newark, New Jersey, 07103
About this study
Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.
- Conditions
- Vaginal Bleeding
- Being tested
- Intrauterine system
- Keywords
- intrauterine device, bleeding
- Medical subject headings
- Uterine Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine systemDevice
Also called Intrauterine device
Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.
| Study group | Role | What they receive |
|---|---|---|
| Early cycle insertion | Participants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle. Receives: Device: Intrauterine system | |
| Late cycle insertion | Participants in this group have the intrauterine system inserted during the remainder of their cycle. Receives: Device: Intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding and spotting as collected by daily texts
Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start16 Apr 2016
- Primary completion27 Jul 2017
- Study completion28 Jul 2017
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 Vaginal BleedingStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noaa Shimoni, Rutgers, The State University of New Jersey
- Investigators
- Noa'a Shimoni, MD MPH, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074903
- Sponsor's protocol ID
- Pro20150001449
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2017
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Shimoni N, Choudhury T, Goldman AR, Frondelli M, Chen PH. Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing. Contraception. 2019 Jun;99(6):340-344. doi: 10.1016/j.contraception.2019.02.004. Epub 2019 Mar 1.
PubMed 30831104
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Skyla Insertion Timing Impact Bleeding?
- ClinicalTrials.gov ID
- NCT03074903
- Acronym / sponsor ID
- Pro20150001449
- Conditions
- Vaginal Bleeding
- Keywords
- intrauterine device, bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 16 Apr 2016 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 28 Jul 2017 (actual)
- First posted
- 9 Mar 2017 (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.
Women presenting for contraception will be offered the IUS Skyla and study participation. Daily bleeding will be collected for a total of 90 days and correlated with insertion timing and baseline endometrial thickness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cycle insertion | – | Device: Intrauterine systemParticipants in this group have the intrauterine system inserted during the first seven days of their menstrual cycle. |
| Late cycle insertion | – | Device: Intrauterine systemParticipants in this group have the intrauterine system inserted during the remainder of their cycle. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women presenting for intrauterine device insertion.
Key inclusion criteria (5 listed)
- Women aged 18-45
- Parous or nulliparous
- Desire Skyla for contraception
- Regular menstrual cycles (21-35 days)
- Working mobile phone and willing to accept text messages and report daily bleeding data for 90 days
Key exclusion criteria (8 listed)
- Vaginal or cesarean delivery in the past 12 weeks
- Abortion in the past 6 weeks
- Uterine anomaly distorting the uterus
- Acute pelvic inflammatory disease
- Uterine bleeding of unknown etiology
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 |
|---|---|---|
| Intrauterine systemAlso: Intrauterine deviceWomen having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts. | Device | Early cycle insertion, Late cycle insertion |
Primary outcome
Bleeding and spotting as collected by daily texts
Time frame: 90 days
Composite variable of bleeding and spotting for 90 days after Skyla IUS insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Derived from this study: PubMed 30831104Shimoni N, Choudhury T, Goldman AR, Frondelli M, Chen PH. Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing. Contraception. 2019 Jun;99(6):340-344. doi: 10.1016/j.contraception.2019.02.004. Epub 2019 Mar 1.
- 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.
Noa'a Shimoni, MD MPH principal investigator
Rutgers University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Bleeding, run by Rutgers, The State University of New Jersey at 3 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 5 inclusion and 8 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 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bleeding and spotting as collected by daily texts (time frame: 90 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 NCT03074903, 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 13 Feb 2018.