AdenomyosisNCT03027648
Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
A study testing Placement of levonorgestrel-releasing intrauterine system in people with Adenomyosis, run by Peking Union Medical College Hospital.
Trial summary
Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis. Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Placement of levonorgestrel-releasing intrauterine system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jan 2017
- Phase
- Interventional
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with regular menses
- Adenomyosis diagnosed via transvaginal ultrasound
- With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores >100)
- Duration of placement > 12 months
- Size of uterus by physical examination less than uterus of 12-week pregnancy
Who cannot join
- Desire for pregnancy or lactation
- With diagnosis of malignancies or precancerous lesions
- Acceptance of laparotomy
- Contraindication of placing levonorgestrel-releasing intrauterine system
About this study
Official title: Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis.
Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.
Read more
Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea
Second outcome measures: carrying status of IUS
- Conditions
- Adenomyosis
- Being tested
- Placement of levonorgestrel-releasing intrauterine system
- Keywords
- levonorgestrel-releasing intrauterine system, adenomyosis
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of levonorgestrel-releasing intrauterine systemProcedure or surgery
All the patients accepted treatment of levonorgestrel-releasing intrauterine system
| Study group | Role | What they receive |
|---|---|---|
| patients with LNG-IUS | Other | Placement of levonorgestrel-releasing intrauterine system Receives: Procedure: Placement of levonorgestrel-releasing intrauterine system |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
visual analogue scale for pain
Measured: 5 years after placement of levonorgestrel-releasing intrauterine system
Secondary outcomes (5)
unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system
Measured: 5 years after placement of levonorgestrel-releasing intrauterine system
spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system
Measured: 5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by verbal rating scales for pain
verbal rating scales for pain
Measured: 5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea
hemoglobin for menorrhea
Measured: 5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea
visual analogue scale for pain
Measured: 5 years after placement of levonorgestrel-releasing intrauterine system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startDec 2006
- Primary completionDec 2014
- Study completionJan 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 AdenomyosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Leng Jinghua, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027648
- Sponsor's protocol ID
- PUMCH-OBGYN-2014
- Status last verified
- Jan 2017
- First submitted
- 15 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD will be shared with researchers via online database
Publications
Li L, Leng J, Jia S, Lang J. Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system. Int J Gynaecol Obstet. 2019 Sep;146(3):357-363. doi: 10.1002/ijgo.12887. Epub 2019 Jun 27.
PubMed 31194884
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis
- ClinicalTrials.gov ID
- NCT03027648
- Acronym / sponsor ID
- PUMCH-OBGYN-2014
- Conditions
- Adenomyosis
- Keywords
- levonorgestrel-releasing intrauterine system, adenomyosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Jan 2017 (estimated)
- 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.
Objective: To investigate the effects of levonorgestrel-releasing intrauterine system (LNG-IUS) for symptomatic adenomyosis.
Methods: From December, 2006 to December, 2014, symptomatic patients of adenomyosis diagnosed (with dysmenorrhea and/or menorrhea) by transvaginal ultrasound in outpatient or inpatient clinics of Peking Union Medical College Hospital were given the treatment of LNG-IUS. Before and after placement of LNG-IUS, during each following period, all the parameters were recorded prospectively, including carrying status of IUS, symptoms and scores of dysmenorrhea, menstruation scores, biochemical indicators, physical parameters, menstruation patterns and adverse effects.
Primary outcome measures: symptoms and scores of dysmenorrhea and menorrhea
Second outcome measures: carrying status of IUS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with LNG-IUS | Other | Procedure: Placement of levonorgestrel-releasing intrauterine systemPlacement of levonorgestrel-releasing intrauterine system |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with regular menses
- Adenomyosis diagnosed via transvaginal ultrasound
- With severe dysmenorrhea (VAS ≥ 7) and/or menorrhea (pictorial chart scores >100)
- Duration of placement > 12 months
- Size of uterus by physical examination less than uterus of 12-week pregnancy
Key exclusion criteria (4 listed)
- Desire for pregnancy or lactation
- With diagnosis of malignancies or precancerous lesions
- Acceptance of laparotomy
- Contraindication of placing levonorgestrel-releasing intrauterine system
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 |
|---|---|---|
| Placement of levonorgestrel-releasing intrauterine systemAll the patients accepted treatment of levonorgestrel-releasing intrauterine system | Procedure or surgery | patients with LNG-IUS |
Primary outcome
improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system
Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
visual analogue scale for pain
5 secondary outcomes
unplanned taking-out rate in percent of levonorgestrel-releasing intrauterine system
Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
spontaneously expulsion rate in percent of levonorgestrel-releasing intrauterine system
Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by verbal rating scales for pain
Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by hemoglobin for menorrhea
Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
improvement of symptoms of adenomyosis assessed by pictorial chart scores for menorrhea
Time frame: 5 years after placement of levonorgestrel-releasing intrauterine system
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 23 Jan 2017.
- Derived from this study: PubMed 31194884Li L, Leng J, Jia S, Lang J. Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system. Int J Gynaecol Obstet. 2019 Sep;146(3):357-363. doi: 10.1002/ijgo.12887. Epub 2019 Jun 27.
- Individual participant dataSharing planned: Yes. IPD will be shared with researchers via online database
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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.
Leng Jinghua, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Placement of levonorgestrel-releasing intrauterine system in people with Adenomyosis, run by Peking Union Medical College Hospital.
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 4 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 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
improvement of symptoms of adenomyosis assessed by change from baseline visual analogue scale at 5 years after placement of levonorgestrel-releasing intrauterine system (time frame: 5 years after placement of levonorgestrel-releasing intrauterine system). 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 NCT03027648, 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 2017.