Endometrial PolypPhase 4NCT03790215
Dydrogesterone in the Treatment of Endometrial Polyps
A Phase 4 study testing Dydrogesterone in people with Endometrial Polyp, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Endometrial Polyp
- What is being tested?
- Dydrogesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 31 Dec 2019
- Phase
- Phase 4
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women of childbearing age from 20 to 50 years old
- with or without menstrual changes:
- menostaxis (longer than 7 days)
- shortened menstrual cycles(less than 23 days)
- menorrhagia(more than twice as much as usual)
- abnormal vaginal bleeding(non-menstrual vaginal bleeding)
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- with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle):
- typical signs with a suspect of EP: (median/high) echo with a regular contour within the uterine lumen;
- atypical signs with a suspect of EP: punctate cystic areas within the endometrium and the endometrial thickness >1cm;
Who cannot join
- no menses within half a year;
- surgery or drug treatment of endometrial lesions in the past half year;
- with current intrauterine device;
- combined with other acute gynecological inflammation;
- with clinically suspected malignant tumors;
- long-term use of oral contraceptives;
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- with abnormal liver and kidney function;
- with benign or malignant breast tumors;
- with any systemic malignant tumor or a history of tumors;
- participants who are pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
Read the detailed description
Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.Based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
- Conditions
- Endometrial Polyp
- Being tested
- Dydrogesterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DydrogesteroneDrug
Also called Duphaston
The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.
| Study group | Role | What they receive |
|---|---|---|
| cohort for treatment | Experimental | Participants enrolled are given dydrogesterone tablet of 10mg twice a day, from day 15 to day 24 of the menstrual cycle over a period of 3 months. Receives: Drug: Dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression rate of endometrial polyps
No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound
Measured: three months after the starting of treatment
Relapse rate of endometrial polyps
Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment
Measured: six months after the starting of treatment
Secondary outcomes (1)
Side effects
Any side effects during the treatment
Measured: three months after the starting of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start1 Feb 2019
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial PolypStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shuwang, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790215
- Sponsor's protocol ID
- EP-1
- Status last verified
- Jan 2020
- First submitted
- 21 Dec 2018
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective One-arm Cohort Study of Dydrogesterone in the Treatment of Endometrial Polyps
- ClinicalTrials.gov ID
- NCT03790215
- Acronym / sponsor ID
- EP-1
- Conditions
- Endometrial Polyp
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 31 Dec 2018 (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.
This study is intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
Detailed description
Endometrial polyps are a common female endometrial lesion.The long-term unrestrained exposure of estrogen to local tissue is one of the causes of polyp formation.Studies suggested that the progesterone can accelerate the regression rate of endometrial polyps due to its antiestrogenic effects.Based on this, investigators intended to observe the therapeutic effect of dydrogesterone on endometrial polyps and provide a reference for clinical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort for treatment | Experimental | Drug: DydrogesteroneParticipants enrolled are given dydrogesterone tablet of 10mg twice a day, from day 15 to day 24 of the menstrual cycle over a period of 3 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- women of childbearing age from 20 to 50 years old
- with or without menstrual changes:
- with following signs of vaginal ultrasound in the follicular phase (day 1 to day 10 of a menstrual cycle):
Key exclusion criteria (10 listed)
- no menses within half a year;
- surgery or drug treatment of endometrial lesions in the past half year;
- with current intrauterine device;
- combined with other acute gynecological inflammation;
- with clinically suspected malignant tumors;
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 |
|---|---|---|
| DydrogesteroneAlso: DuphastonThe investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects. | Drug | cohort for treatment |
Primary outcome
Regression rate of endometrial polyps
Time frame: three months after the starting of treatment
No evidence of polyps or the maximum dimensions of polyps are reduced by 1/3 or more under pelvic ultrasound
Relapse rate of endometrial polyps
Time frame: six months after the starting of treatment
Evidence of polyps or the maximum dimensions of polyps are larger during the follow-up of the regression group after treatment
1 secondary outcome
Side effects
Time frame: three months after the starting of treatment
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 22 Jan 2020.
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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 Dydrogesterone in people with Endometrial Polyp, run by Peking Union Medical College Hospital at 1 site in China.
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 9 inclusion and 10 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 22 Jan 2020. 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 China. 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.
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?
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?
Regression rate of endometrial polyps (time frame: three months after the starting of treatment). 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?
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 22 Jan 2020.