Uterine AdhesionsPhase 2/3NCT05635071
Prospective Clinical Study of Nintedanib to Inhibit Endometrial Fibrosis to Prevent Recurrence of Uterine Adhesions
A Phase 2/3 study testing Nintedanib 100 MG [Ofev] and Nintedanib 150 MG [Ofev] in people with Uterine Adhesions, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
In moderate to severe cavity adhesions, the endometrial basal layer is more severely damaged and the regenerative capacity of the endometrium and glands is low. Even though hysteroscopic electrosurgery can roughly restore the cavity morphology, the postoperative recurrence rate is as high as 40%. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Uterine Adhesions
- What is being tested?
- Nintedanib 100 MG [Ofev] and Nintedanib 150 MG [Ofev]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Dec 2024
- 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1)Clinical diagnosis of uterine adhesions; 2)Body mass index between 18-27 kg/m2; 3)Have a regular menstrual cycle of 27-35 days for at least six months; 4)Hysteroscopic diagnosis of moderate to severe uterine adhesions (AFS score >5), treated with electrodesiccation; 5)No contraindications to oral estrogen and progestin such as a history of thrombosis/breast tumor/history of abnormal liver function/migraine; 6)≥ 2 oocytes or blastocysts have been frozen.
Who cannot join
- 1)Patients with combined ovarian cysts ≥ 20 mm in diameter, submucosal uterine fibroids or intermuscular fibroids > 30 mm in diameter, pituitary tumors, and malignant tumors of various tissues and organs; 2)Patients with clinically significant abnormalities of the uterus (endometrial polyps, uterine malformations, endometriosis) and adnexa (hydrosalpinx); 3)Repeated implantation failures, such as three consecutive transfers with ≥6 failed high-quality embryos; 4)Known malformations of the reproductive organs that are unsuitable for pregnancy; 5)Abnormal cervical cytology (TCT) findings within 1 year before the screening; 6)Severe liver or kidney impairment, heart disease, or hypertension; 7)Known previous or current history of thrombophlebitis or thromboembolic disease; 8)Any known clinically significant systemic disease (e.g., diabetes mellitus, tuberculosis, etc; 9)Known history of recurrent miscarriage; 10)Chromosomal karyotype abnormalities in either spouse; 11)Genetic disorders that make either spouse unsuitable for childbirth as specified in the Maternal and Child Health Law;12)exposure of either spouse to teratogenic amounts of radiation, toxins, and drugs; 13)Participation in another drug or medical device clinical trial within 3 months before enrollment;14)Any medical condition/combined surgery/ medication/other clinically significant abnormal laboratory tests that, in the judgment of the investigator, may affect the outcome of the trial; 15)Known refusal or inability to comply with protocol requirements for any reason (including planned clinical visits and examinations).
About this study
In moderate to severe cavity adhesions, the endometrial basal layer is more severely damaged and the regenerative capacity of the endometrium and glands is low. Even though hysteroscopic electrosurgery can roughly restore the cavity morphology, the postoperative recurrence rate is as high as 40%. Abnormal uterine cavity morphology and poor endometrial repair often lead to repeated cancellation of embryo transfer cycles in assisted reproduction treatment, and reduced clinical pregnancy rate, causing mental stress and financial burden to patients, which is one of the current problems in clinically assisted reproduction treatment. Nintedanib is a triple vascular kinase inhibitor that acts primarily on platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR) and has been approved by the FDA for the clinical treatment of idiopathic pulmonary fibrosis and systemic sclerosis. The investigator's preliminary animal study found that endometrial fibrosis was significantly reduced in mice with gastric feeding of nintedanib in uterine adhesion molds. This study aimed to clarify further the role of nintedanib in inhibiting endometrial fibrosis and its clinical application value.
Read the detailed description
The experiment will be divided into two groups based on the dose administered. After hysteroscopic surgery, one group will be given Nedanib 100mg bid orally for 15 days and the other group will be given Nedanib 150mg bid orally for 15 days. Hysteroscopic AFS scores and endometrial tissues before and after treatment will be collected for molecular biology experiments.
- Conditions
- Uterine Adhesions
- Being tested
- Nintedanib 100 MG [Ofev], Nintedanib 150 MG [Ofev]
- Keywords
- uterine adhesions, endometrail fibrisis
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib 100 MG [Ofev]Drug
Also called Nintedanib 100 MG Oral Capsule
Nintedanib 100mg bid *15 days orally after hysteroscopic surgery
Nintedanib 150 MG [Ofev]Drug
Also called Nintedanib 150 MG Oral Capsule
Nintedanib 150mg bid *15 days orally after hysteroscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Nintedanib 100mg | Experimental | Traditional hormone replacement (HRT) cycle medication (Tegretol 2mg bid for 20 days, followed by Darvon 10mg bid for the last 10 days) + Nintedanib 100mg bid *15 days orally. Receives: Drug: Nintedanib 100 MG [Ofev] |
| Nintedanib 150mg | Experimental | Traditional hormone replacement (HRT) cycle medication (Tegretol 2mg bid for 20 days, followed by Darvon 10mg bid for the last 10 days) + Nintedanib 150mg bid *15 days orally. Receives: Drug: Nintedanib 150 MG [Ofev] |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Fertility Association(AFS) score (mild:1-4，moderate：5-8，severe：9-12）
American Fertility Association(AFS) scoring performed hysteroscopically
Measured: 3 months
Secondary outcomes (1)
Endometrial thickness
Endometrial thickness measured by ultrasonography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine AdhesionsStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635071
- Sponsor's protocol ID
- 2022ZSLYEC-492
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 2 Dec 2022
- 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 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Nintedanib to Inhibit Endometrial Fibrosis to Prevent Recurrence of Uterine Adhesions
- ClinicalTrials.gov ID
- NCT05635071
- Acronym / sponsor ID
- 2022ZSLYEC-492
- Conditions
- Uterine Adhesions
- Keywords
- uterine adhesions, endometrail fibrisis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Dec 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 moderate to severe cavity adhesions, the endometrial basal layer is more severely damaged and the regenerative capacity of the endometrium and glands is low. Even though hysteroscopic electrosurgery can roughly restore the cavity morphology, the postoperative recurrence rate is as high as 40%. Abnormal uterine cavity morphology and poor endometrial repair often lead to repeated cancellation of embryo transfer cycles in assisted reproduction treatment, and reduced clinical pregnancy rate, causing mental stress and financial burden to patients, which is one of the current problems in clinically assisted reproduction treatment. Nintedanib is a triple vascular kinase inhibitor that acts primarily on platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR) and has been approved by the FDA for the clinical treatment of idiopathic pulmonary fibrosis and systemic sclerosis. The investigator's preliminary animal study found that endometrial fibrosis was significantly reduced in mice with gastric feeding of nintedanib in uterine adhesion molds. This study aimed to clarify further the role of nintedanib in inhibiting endometrial fibrosis and its clinical application value.
Detailed description
The experiment will be divided into two groups based on the dose administered. After hysteroscopic surgery, one group will be given Nedanib 100mg bid orally for 15 days and the other group will be given Nedanib 150mg bid orally for 15 days. Hysteroscopic AFS scores and endometrial tissues before and after treatment will be collected for molecular biology experiments.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nintedanib 100mg | Experimental | Drug: Nintedanib 100 MG [Ofev]Traditional hormone replacement (HRT) cycle medication (Tegretol 2mg bid for 20 days, followed by Darvon 10mg bid for the last 10 days) + Nintedanib 100mg bid *15 days orally. |
| Nintedanib 150mg | Experimental | Drug: Nintedanib 150 MG [Ofev]Traditional hormone replacement (HRT) cycle medication (Tegretol 2mg bid for 20 days, followed by Darvon 10mg bid for the last 10 days) + Nintedanib 150mg bid *15 days orally. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1)Clinical diagnosis of uterine adhesions; 2)Body mass index between 18-27 kg/m2; 3)Have a regular menstrual cycle of 27-35 days for at least six months; 4)Hysteroscopic diagnosis of moderate to severe uterine adhesions (AFS score >5), treated with electrodesiccation; 5)No contraindications to oral estrogen and progestin such as a history of thrombosis/breast tumor/history of abnormal liver function/migraine; 6)≥ 2 oocytes or blastocysts have been frozen.
Key exclusion criteria (1 listed)
- 1)Patients with combined ovarian cysts ≥ 20 mm in diameter, submucosal uterine fibroids or intermuscular fibroids > 30 mm in diameter, pituitary tumors, and malignant tumors of various tissues and organs; 2)Patients with clinically significant abnormalities of the uterus (endometrial polyps, uterine malformations, endometriosis) and adnexa (hydrosalpinx); 3)Repeated implantation failures, such as three consecutive transfers with ≥6 failed high-quality embryos; 4)Known malformations of the reproductive organs that are unsuitable for pregnancy; 5)Abnormal cervical cytology (TCT) findings within 1 year before the screening; 6)Severe liver or kidney impairment, heart disease, or hypertension; 7)Known previous or current history of thrombophlebitis or thromboembolic disease; 8)Any known clinically significant systemic disease (e.g., diabetes mellitus, tuberculosis, etc; 9)Known history of recurrent miscarriage; 10)Chromosomal karyotype abnormalities in either spouse; 11)Genetic disorders that make either spouse unsuitable for childbirth as specified in the Maternal and Child Health Law;12)exposure of either spouse to teratogenic amounts of radiation, toxins, and drugs; 13)Participation in another drug or medical device clinical trial within 3 months before enrollment;14)Any medical condition/combined surgery/ medication/other clinically significant abnormal laboratory tests that, in the judgment of the investigator, may affect the outcome of the trial; 15)Known refusal or inability to comply with protocol requirements for any reason (including planned clinical visits and examinations).
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 |
|---|---|---|
| Nintedanib 100 MG [Ofev]Also: Nintedanib 100 MG Oral CapsuleNintedanib 100mg bid *15 days orally after hysteroscopic surgery | Drug | Nintedanib 100mg |
| Nintedanib 150 MG [Ofev]Also: Nintedanib 150 MG Oral CapsuleNintedanib 150mg bid *15 days orally after hysteroscopic surgery | Drug | Nintedanib 150mg |
Primary outcome
American Fertility Association(AFS) score (mild:1-4，moderate：5-8，severe：9-12）
Time frame: 3 months
American Fertility Association(AFS) scoring performed hysteroscopically
1 secondary outcome
Endometrial thickness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nintedanib 100 MG [Ofev] and Nintedanib 150 MG [Ofev] in people with Uterine Adhesions, run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 1 inclusion and 1 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 2 Dec 2022. 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.
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?
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?
American Fertility Association(AFS) score (mild:1-4，moderate：5-8，severe：9-12） (time frame: 3 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 2 Dec 2022.