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Pharmacological Preparation of the Cervix for Hysteroscopy

Primary Purpose

Uterine Polyp, Uterine Bleeding, Endometrium; Senility

Status

Completed

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

estradiol

Hyaluronic acid

About this trial

This is an interventional treatment trial for Uterine Polyp

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: age 45-90 years uterine cavity focal lesion, abnormal uterine bleeding Exclusion Criteria: drug allergy no consent to the procedure or participation in the study

Sites / Locations

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

1 (estradiol)

2 (hyaluronic acid)

3 (control)

Arm Description

estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure

hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

no preparation of the cervix - arm without medication

Outcomes

Primary Outcome Measures

Intensification of pain during and after the procedure

Intensity of pain in Numeric Rating Scale (NRS: 0-10)

The need of cervical dilation

The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity

Secondary Outcome Measures

Cervical passage time

Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity

Occurrence of a vasovagal reaction

the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)

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

Full Information

NCT ID

NCT05783479

First Posted

March 11, 2023

Last Updated

March 23, 2023

Sponsor

Jagiellonian University

1. Study Identification

Unique Protocol Identification Number

NCT05783479

Brief Title

Pharmacological Preparation of the Cervix for Hysteroscopy

Official Title

Estriol and Hyaluronic Acid in Cervical Preparation for Mini-hysteroscopy in Peri- and Postmenopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

December 30, 2022 (Actual)

Study Completion Date

January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uterine Polyp, Uterine Bleeding, Endometrium; Senility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 (estradiol)

Arm Type

Active Comparator

Arm Description

estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure

Arm Title

2 (hyaluronic acid)

Arm Type

Active Comparator

Arm Description

hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Arm Title

3 (control)

Arm Type

No Intervention

Arm Description

no preparation of the cervix - arm without medication

Intervention Type

Drug

Intervention Name(s)

estradiol

Intervention Description

estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure

Intervention Type

Drug

Intervention Name(s)

Hyaluronic acid

Intervention Description

hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Primary Outcome Measure Information:

Title

Intensification of pain during and after the procedure

Description

Intensity of pain in Numeric Rating Scale (NRS: 0-10)

Time Frame

up to 6 months

Title

The need of cervical dilation

Description

The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Cervical passage time

Description

Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity

Time Frame

up to 6 months

Title

Occurrence of a vasovagal reaction

Description

the occurrence of a vasovagal reaction (fall in blood pressure, bradycardia, syncope)

Time Frame

up to 6 months

Title

Occurrence of severe urogenital atrophy (paleness and thinning of the vaginal epithelium, petechiae and shallow ulcers, bleeding and contact)

Description

Clinical evaluation of the occurrence of symptoms of urogenital atrophy

Time Frame

up to 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 45-90 years uterine cavity focal lesion, abnormal uterine bleeding Exclusion Criteria: drug allergy no consent to the procedure or participation in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Jach, Prof.

Organizational Affiliation

Jagiellonian University

Official's Role

Study Chair

Facility Information:

Facility Name

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

City

Kraków

ZIP/Postal Code

31-501

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Pharmacological Preparation of the Cervix for Hysteroscopy

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