Fertility SparingPhase 2/3NCT05565573
Medroxyprogesterone Acetate vs LNG-IUS in Early-stage Endometrioid Carcinoma and Atypical Hyperplasia Patients
A Phase 2/3 study testing Medroxyprogesterone Acetate 500 MG Oral Tablet and Levonorgestrel-Releasing Intrauterine System in people with Fertility Sparing, run by Hua Li at 1 site in China.
Trial summary
In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Fertility Sparing
- What is being tested?
- Medroxyprogesterone Acetate 500 MG Oral Tablet and Levonorgestrel-Releasing Intrauterine System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Nov 2025
- Phase
- Phase 2/3
- 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age ≤ 45 years old;
- Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma;
- pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium;
- No suspicious metastatic lesions;
- Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors;
- Blood CA125 is normal;
Show all 9Show fewer
- no progesterone therapy and contraindications to pregnancy;
- The patient himself has a strong desire to preserve fertility, and the patient should fully understand that fertility preservation treatment is not the standard treatment method;
- Conditional acceptance of close follow-up.
Who cannot join
- type II endometrial cancer;
- Patients with abnormal liver and kidney function and other contraindications to progesterone therapy;
- Other parts of the body are concurrent or successively complicated by other malignant tumors;
- The patient and his/her family are unable to sign the informed consent form for any reason;
- Unconditional follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Bei Jing Chao-Yang Hospital
Beijing, Beijing Municipality, 100025
Hua Li, Ph.D, +86 010 85231831
About this study
Official title: The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients
- Conditions
- Fertility Sparing
- Being tested
- Medroxyprogesterone Acetate 500 MG Oral Tablet, Levonorgestrel-Releasing Intrauterine System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medroxyprogesterone Acetate 500 MG Oral TabletDrug
Also called MPA
500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day
Levonorgestrel-Releasing Intrauterine SystemDevice
Also called LNG-IUS, 52-mg LNG-IUS，Mirena
Uterine cavity insertion
| Study group | Role | What they receive |
|---|---|---|
| Medroxyprogesterone acetate | Experimental | Administered MPA at a dosage of 500 mg/d concurrently Receives: Drug: Medroxyprogesterone Acetate 500 MG Oral Tablet |
| LNG-IUS | Experimental | Go through LNG-IUS insertion Receives: Device: Levonorgestrel-Releasing Intrauterine System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
The 24-week CR rate will be calculated in two groups.
Measured: 24-week
Secondary outcomes (3)
Time to achieve complete response
The median CR time will be calculated in two groups
Measured: From date of randomization until the date of CR, assessed up to 24 weeks
The pregnancy rate
Rate of fertility outcomes
Measured: Up to 2 years after the treatment
The live-birth rate
Rate of fertility outcomes
Measured: Up to 2 years after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility SparingStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Li, Beijing Chao Yang Hospital
- Investigators
- Hua Li, Ph.D, Study chair, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565573
- Sponsor's protocol ID
- LH0930
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma
- ClinicalTrials.gov ID
- NCT05565573
- Acronym / sponsor ID
- LH0930
- Conditions
- Fertility Sparing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Hua LiUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 4 Oct 2022 (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.
In modern society, endometrial cancer (EC) and atypical hyperplasia is the most frequent desease which can affect the fertility of young patients. For young patients, there is a growing need to treat tumors and fertility sparing. Advaced studies have confirmed thatfertility preservation therapy has better tumor and pregnancy outcomes in specific patients with early gynecological tumors. Clinically, evidence-based guidelines are urgently needed to guide the screening and treatment of women who are suitable for fertility preservation. Fertility-sparing treatment predominantly involves the use of oral progestins and levonorgestrel-releasing intrauterine devices, which have been shown to be feasible and safe in women with early stage EC and minimal or no myometrial invasion. However, data on the efficacy and safety of conservative management strategies are primarily based on retrospective studies.The present study aims to compared the therapeutic effect of Medroxyprogesterone acetate (MPA) and Levonorgestrel-releasing intrauterine system (LNG-IUS) in early-stage endometrioid carcinoma and atypical hyperplasia patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medroxyprogesterone acetate | Experimental | Drug: Medroxyprogesterone Acetate 500 MG Oral TabletAdministered MPA at a dosage of 500 mg/d concurrently |
| LNG-IUS | Experimental | Device: Levonorgestrel-Releasing Intrauterine SystemGo through LNG-IUS insertion |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age ≤ 45 years old;
- Diagnostic curettage pathology is highly differentiated endometrioid adenocarcinoma;
- pelvic augmentation MRI or / and vaginal color ultrasound Doppler examination, tumor confined endometrium;
- No suspicious metastatic lesions;
- Endometrial pathological tissue specimens with strong positive expression of estrogen and progesterone receptors;
Key exclusion criteria (5 listed)
- type II endometrial cancer;
- Patients with abnormal liver and kidney function and other contraindications to progesterone therapy;
- Other parts of the body are concurrent or successively complicated by other malignant tumors;
- The patient and his/her family are unable to sign the informed consent form for any reason;
- Unconditional follow-up.
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 Acetate 500 MG Oral TabletAlso: MPA500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate At a dosage of 500 mg/day | Drug | Medroxyprogesterone acetate |
| Levonorgestrel-Releasing Intrauterine SystemAlso: LNG-IUS, 52-mg LNG-IUS，MirenaUterine cavity insertion | Device | LNG-IUS |
Primary outcome
Complete response rate
Time frame: 24-week
The 24-week CR rate will be calculated in two groups.
3 secondary outcomes
Time to achieve complete response
Time frame: From date of randomization until the date of CR, assessed up to 24 weeks
The pregnancy rate
Time frame: Up to 2 years after the treatment
The live-birth rate
Time frame: Up to 2 years after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Fertility Sparing
Not yet recruitingPhase 2
A Preliminary Exploratory Study of Cadonilimab Combined With Progestin for Fertility-Sparing Treatment in Early Endometrial Cancer
Endometrial Cancer
Active, not recruitingPhase 2
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer
Endometrial Neoplasm Malignant Stage I
Not yet recruitingPhase 2
Canagliflozin Plus Progestin for Atypical Endometrial Hyperplasia and Early-Stage Endometrial Cancer
Endometrioid Endometrial Cancer, Atypical Endometrial Hyperplasia
RecruitingPhase 2
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
Endometrial Cancer, Atypical Hyperplasia
Not yet recruitingPhase 2
Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer
Endometrial Atypical Hyperplasia, Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia
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.
Hua Li, Ph.D study chair
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Medroxyprogesterone Acetate 500 MG Oral Tablet and Levonorgestrel-Releasing Intrauterine System in people with Fertility Sparing, run by Hua Li 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 5 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 4 Oct 2022. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hengzi Sun, Ph.D (+86 18811151901, summerel1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 24-week). 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 4 Oct 2022.