Pharmacological Preparation of the Cervix for Hysteroscopy

Sponsor

Jagiellonian University (Other)

Overall Status

Completed

CT.gov ID

NCT05783479

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Polyp Uterine Bleeding Endometrium; Senility	Drug: estradiol Drug: Hyaluronic acid	N/A

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

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Actual Primary Completion Date :

Dec 30, 2022

Actual Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 (estradiol) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure	Drug: estradiol estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
Active Comparator: 2 (hyaluronic acid) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure	Drug: Hyaluronic acid hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
No Intervention: 3 (control) no preparation of the cervix - arm without medication

Arm

Intervention/Treatment

Active Comparator: 1 (estradiol)

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

Drug: estradiol

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

Active Comparator: 2 (hyaluronic acid)

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

Drug: Hyaluronic acid

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

No Intervention: 3 (control)

no preparation of the cervix - arm without medication

Outcome Measures

Primary Outcome Measures

Intensification of pain during and after the procedure [up to 6 months]
Intensity of pain in Numeric Rating Scale (NRS: 0-10)
The need of cervical dilation [up to 6 months]
The need for cervical dilation (yes/no) to penetrate the cervix and enter the uterine cavity

Secondary Outcome Measures

Cervical passage time [up to 6 months]
Cervical penetration time (minutes) from visualization of the external cervical os to reaching the uterine cavity
Occurrence of a vasovagal reaction [up to 6 months]
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) [up to 6 months]
Clinical evaluation of the occurrence of symptoms of urogenital atrophy

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jagiellonian University Medical College, Department of Gynecology and Obstetrics	Kraków		Poland	31-501

Sponsors and Collaborators

Jagiellonian University

Investigators

Study Chair: Robert Jach, Prof., Jagiellonian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Iwona Magdalena Gawron, Ph.D., Principal Investigator, Jagiellonian University

ClinicalTrials.gov Identifier:

NCT05783479

Other Study ID Numbers:

1072.6120.128.2021

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Hemorrhage

Estradiol

Hyaluronic Acid

Study Results

No Results Posted as of Mar 24, 2023