Uterine PolypNCT05783479
Pharmacological Preparation of the Cervix for Hysteroscopy
A study testing estradiol and Hyaluronic acid in people with Uterine Polyp and Uterine Bleeding, run by Jagiellonian University at 1 site in Poland.
Trial summary
Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. Read more about this study
- Who is it for?
- Ages 45 to 90 years, women only
- Conditions the study is for
- Uterine Polyp, Uterine Bleeding, Endometrium; Senility
- What is being tested?
- estradiol and Hyaluronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2022to 31 Jan 2023
- 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 45 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 45-90 years
- uterine cavity focal lesion, abnormal uterine bleeding
Who cannot join
- drug allergy
- no consent to the procedure or participation in the study
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Krakow, 31-501
About this study
Official title: Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women
Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.
Read the detailed description
A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).
- Conditions
- Uterine Polyp, Uterine Bleeding, Endometrium; Senility
- Being tested
- estradiol, Hyaluronic acid
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
estradiolDrug
estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
Hyaluronic acidDrug
hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 (estradiol) | Active comparator | estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure Receives: Drug: estradiol |
| 2 (hyaluronic acid) | Active comparator | hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure Receives: Drug: Hyaluronic acid |
| 3 (control) | No intervention | no preparation of the cervix - arm without medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensification of pain during and after the procedure
Intensity of pain in Numeric Rating Scale (NRS: 0-10)
Measured: up to 6 months
The need of cervical dilation
The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity
Measured: up to 6 months
Secondary outcomes (3)
Cervical passage time
Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity
Measured: up to 6 months
Occurrence of a vasovagal reaction
the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)
Measured: up to 6 months
Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)
Clinical evaluation of the occurrence of symptoms of urogenital atrophy
Measured: 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 posted24 Mar 2023
- Study start1 Jun 2022
- Primary completion30 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine PolypStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of endpoints in three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control).
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Magdalena Gawron, Jagiellonian University
- Investigators
- Robert Jach, Prof., Study chair, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783479
- Sponsor's protocol ID
- 1072.6120.128.2021
- Status last verified
- Mar 2023
- First submitted
- 11 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05783479
- Acronym / sponsor ID
- 1072.6120.128.2021
- Conditions
- Uterine Polyp, Uterine Bleeding, Endometrium; Senility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 24 Mar 2023 (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.
Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.
Detailed description
A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparison of endpoints in three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control).
| Arm | Type | Receives |
|---|---|---|
| 1 (estradiol) | Active comparator | Drug: estradiolestradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure |
| 2 (hyaluronic acid) | Active comparator | Drug: Hyaluronic acidhyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure |
| 3 (control) | No intervention | –no preparation of the cervix - arm without medication |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 45-90 years
- uterine cavity focal lesion, abnormal uterine bleeding
Key exclusion criteria (2 listed)
- drug allergy
- no consent to the procedure or participation in the study
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 |
|---|---|---|
| estradiolestradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure | Drug | 1 (estradiol) |
| Hyaluronic acidhyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure | Drug | 2 (hyaluronic acid) |
Primary outcome
Intensification of pain during and after the procedure
Time frame: up to 6 months
Intensity of pain in Numeric Rating Scale (NRS: 0-10)
The need of cervical dilation
Time frame: up to 6 months
The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity
3 secondary outcomes
Cervical passage time
Time frame: up to 6 months
Occurrence of a vasovagal reaction
Time frame: up to 6 months
Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)
Time frame: 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 24 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Uterine Polyp
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
RecruitingPhase 1/2
FOG-001 in Locally Advanced or Metastatic Solid Tumors
Cancer, Colorectal Cancer
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
RecruitingObservational study
Discovering New Targets for Colorectal and Endometrial Cancer Risk Reduction
Colorectal Cancer, Endometrial Cancer
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.
Robert Jach, Prof. study chair
Jagiellonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing estradiol and Hyaluronic acid in people with Uterine Polyp and Uterine Bleeding, run by Jagiellonian University at 1 site in Poland.
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 2 inclusion and 2 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 24 Mar 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 Poland. 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.
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?
Intensification of pain during and after the procedure (time frame: up to 6 months). 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 24 Mar 2023.