Endometrial Hyperplasia Without AtypiaPhase 3NCT03675139
MPA Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
A Phase 3 study testing Medroxyprogesterone Acetate and Dydrogesterone 10 MG in people with Endometrial Hyperplasia Without Atypia, run by Xiaojun Chen at 1 site in China.
Trial summary
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometrial Hyperplasia Without Atypia
- What is being tested?
- Medroxyprogesterone Acetate and Dydrogesterone 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2019to 15 May 2022
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Pathologically confirmed diagnosis of endometrial hyperplasia without atypia;
- Consent informed and signed;
- Able to follow treatment and take therapy in Obstetrics and Gynecology of Fudan University
Who cannot join
- Liver disease or liver tumor (benign or malignant)
- Kidney disease or kidney tumor (benign or malignant)
- Other malignancies in reproductive organs
- Breast cancer or other progesterone-dependent tumors
- History of endometrial atypical hyperplasia or endometrial cancer
- Any contradictions against progesterone
Show all 9Show fewer
- Under treatment of progestin therapy or oral conceptive drugs one month before enrollment.
- Pregnancy or suspicion of pregnancy
- Ask for other treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011
About this study
Official title: Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.
Read the detailed description
Patients pathologically diagnosed with nonatypical simple or complex EH will be enrolled. Exclusion criteria include malignancy, liver disease or liver tumor (benign or malignant), kidney disease or kidney tumor (benign or malignant), any contradictions against progesterone, history of endometrial atypical hyperplasia or endometrial cancer, any progesterone-dependent tumors, ask for other treatment.
A detailed history including menstruation, fertility, other diseases and family history will be collected. Basic information including age, waist circumstances, hip circumstances and blood pressure will also be collected. Blood tests including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids, liver and kidney functions will be performed before taking progesterone orally.
All enrolled and consent informed patients will be randomized into two groups, A and B, using computer-generated random numbers. Patients in group A will orally take MPA (Medroxyprogesterone Acetate) (angonghuangtitong, Xianju pharmaceuticals, China)10mg daily from tenth day of menstruation for 15 days for 3-6months. While patients in group B will take dydrogesterone (duphaston; Abbott Healthcare Products B.V, the Netherlands) 10 mg, 2 tablets twice daily from fifth day of menstruation for 20 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium.
Complete response (CR) is defined as the reversion of EH to proliferative or secretory endometrium; partial response (PR) is defined as regression to disordered proliferative endometrium (DPE) or simple hyperplasia without atypic (only for complex hyperplasia); no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions.
Another 3-month therapy will be continued if the patients get NR. The longest treatment periods will be 6 months. If the patient gets PD or NR after 6 months therapy, new options must be put.
At least 3-month maintenance therapy will be recommended for patients get CR. And all of the enrolled patients will be followed up for 2 years. All data of the therapy, reverse events, side effects, pregnancy and long-term outcomes will be collected.
- Conditions
- Endometrial Hyperplasia Without Atypia
- Being tested
- Medroxyprogesterone Acetate, Dydrogesterone 10 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone AcetateDrug
Also called Provera
At a dosage of 10mg/day
Dydrogesterone 10 MGDrug
Also called Duphaston
At a dosage of 20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Medroxyprogesterone Acetate | Experimental | EH patients will take MPA (Medroxyprogesterone Acetate) 10mg daily from tenth day of menstruation for 15 days for 3months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. All of the findings will be recorded. Receives: Drug: Medroxyprogesterone Acetate |
| dydrogesterone | Experimental | EH patients will take dydrogesterone 10 mg, 2 tablets twice daily from tenth day of menstruation for 15 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3-month to examine the endometrium. All of the findings will be recorded. Receives: Drug: Dydrogesterone 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (CR) rates
The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH).
Measured: From date of randomization until the date of CR, assessed up to 6 months
Secondary outcomes (6)
Median time of pathological complete response (CR)
Median time of histologic regression from endometrial hyperplasia without atypia to normal endometrium, and comparison will be performed between two treatments and two lesions (SH vs CH).
Measured: From date of randomization until the date of CR, assessed up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Adverse events related with MPA (Medroxyprogesterone acetate
) or dydrogesterone include acne, irregular bleeding, breast tenderness, decreased scalp hair, difficulty falling or remaining asleep, stomach pain, and weight loss or gain, depression and mood changes. Severe side effects include thrombus and impaired liver and kidney function. The investigators will record any symptoms, evaluate the correlation and count the events. And comparison will be performed between two treatments and two lesions (SH vs CH).
Measured: up to 2 years after the treatment for each patient
Relapse rates
All enrolled patients will be followed up for 2 years. During the following-up period, if patients recur after complete regression, they will be counted and the number of recurrence will be divided by number of patients followed up, then we can get the relapse rates.Comparison will be performed between two treatments and two lesions (SH vs CH).
Measured: up to 2 years after the treatment for each patient
Rate of pregnancy
For patients have a desire for fertility, pregnancies, births and related outcomes will be counted, and the rate of pregnancy will be counted as number of pregnancies/ number of patients trying to fertility in the following period. Comparison will be performed between two treatments and two lesions (SH vs CH).
Measured: up to 2 years after the treatment for each patient
Compliance
The investigators designed a questionnaire to evaluate the compliance through treatment. Comparison will be performed between two treatments and two lesions (SH vs CH).
Measured: up to 2 years after the treatment for each patient
cost
Treatment-related cost in each patient during the period beginning from randomization to the date of CR.Comparison will be performed between two treatments and two lesions (SH vs CH).
Measured: From date of randomization until the date of CR, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start26 Feb 2019
- Primary completion14 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial Hyperplasia Without AtypiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaojun Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaojun Chen, Fudan University
- Investigators
- Xiaojun Chen, PhD, Study chair, Obstetrics & Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675139
- Sponsor's protocol ID
- 53201014
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2018
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia
- ClinicalTrials.gov ID
- NCT03675139
- Acronym / sponsor ID
- 53201014
- Conditions
- Endometrial Hyperplasia Without Atypia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Xiaojun ChenUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 14 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 18 Sep 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.
To compare the efficacy of Medroxyprogesterone Acetate with dydrogesterone in patients having endometrial hyperplasia (EH) without atypia.
Detailed description
Patients pathologically diagnosed with nonatypical simple or complex EH will be enrolled. Exclusion criteria include malignancy, liver disease or liver tumor (benign or malignant), kidney disease or kidney tumor (benign or malignant), any contradictions against progesterone, history of endometrial atypical hyperplasia or endometrial cancer, any progesterone-dependent tumors, ask for other treatment.
A detailed history including menstruation, fertility, other diseases and family history will be collected. Basic information including age, waist circumstances, hip circumstances and blood pressure will also be collected. Blood tests including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids, liver and kidney functions will be performed before taking progesterone orally.
All enrolled and consent informed patients will be randomized into two groups, A and B, using computer-generated random numbers. Patients in group A will orally take MPA (Medroxyprogesterone Acetate) (angonghuangtitong, Xianju pharmaceuticals, China)10mg daily from tenth day of menstruation for 15 days for 3-6months. While patients in group B will take dydrogesterone (duphaston; Abbott Healthcare Products B.V, the Netherlands) 10 mg, 2 tablets twice daily from fifth day of menstruation for 20 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium.
Complete response (CR) is defined as the reversion of EH to proliferative or secretory endometrium; partial response (PR) is defined as regression to disordered proliferative endometrium (DPE) or simple hyperplasia without atypic (only for complex hyperplasia); no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions.
Another 3-month therapy will be continued if the patients get NR. The longest treatment periods will be 6 months. If the patient gets PD or NR after 6 months therapy, new options must be put.
At least 3-month maintenance therapy will be recommended for patients get CR. And all of the enrolled patients will be followed up for 2 years. All data of the therapy, reverse events, side effects, pregnancy and long-term outcomes will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medroxyprogesterone Acetate | Experimental | Drug: Medroxyprogesterone AcetateEH patients will take MPA (Medroxyprogesterone Acetate) 10mg daily from tenth day of menstruation for 15 days for 3months. Endometrial Biopsy (Pipelle) will be performed every 3 months to examine the endometrium. All of the findings will be recorded. |
| dydrogesterone | Experimental | Drug: Dydrogesterone 10 MGEH patients will take dydrogesterone 10 mg, 2 tablets twice daily from tenth day of menstruation for 15 days for 3-6 months. Endometrial Biopsy (Pipelle) will be performed every 3-month to examine the endometrium. All of the findings will be recorded. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pathologically confirmed diagnosis of endometrial hyperplasia without atypia;
- Consent informed and signed;
- Able to follow treatment and take therapy in Obstetrics and Gynecology of Fudan University
Key exclusion criteria (9 listed)
- Liver disease or liver tumor (benign or malignant)
- Kidney disease or kidney tumor (benign or malignant)
- Other malignancies in reproductive organs
- Breast cancer or other progesterone-dependent tumors
- History of endometrial atypical hyperplasia or endometrial cancer
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 |
|---|---|---|
| Medroxyprogesterone AcetateAlso: ProveraAt a dosage of 10mg/day | Drug | Medroxyprogesterone Acetate |
| Dydrogesterone 10 MGAlso: DuphastonAt a dosage of 20 mg/day | Drug | dydrogesterone |
Primary outcome
Pathological complete response (CR) rates
Time frame: From date of randomization until the date of CR, assessed up to 6 months
The CR rates will be calculated after 3 and 6-month therapy based on the following formula: (Number of participants who got CR)/(All enrolled participants). The CR rates will be compared between two therapies (MPA VS dydrogesterone), also between two lesions (SH VS CH).
6 secondary outcomes
Median time of pathological complete response (CR)
Time frame: From date of randomization until the date of CR, assessed up to 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 2 years after the treatment for each patient
Relapse rates
Time frame: up to 2 years after the treatment for each patient
Rate of pregnancy
Time frame: up to 2 years after the treatment for each patient
Compliance
Time frame: up to 2 years after the treatment for each patient
cost
Time frame: From date of randomization until the date of CR, assessed up to 6 months
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 17 Feb 2023.
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Atypical Endometrial Hyperplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
Active, not recruitingPhase 2
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy
Atypical Endometrial Hyperplasia, Endometrial Carcinoma
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.
Xiaojun Chen, PhD study chair
Obstetrics & Gynecology Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medroxyprogesterone Acetate and Dydrogesterone 10 MG in people with Endometrial Hyperplasia Without Atypia, run by Xiaojun Chen 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 3 inclusion and 9 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 17 Feb 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Pathological complete response (CR) rates (time frame: From date of randomization until the date of CR, assessed up to 6 months). 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 17 Feb 2023.