Pharmacological Preparation of the Cervix for Hysteroscopy

NCT05783479 | Completed DMC

• 1 other identifier: 1072.6120.128.2021
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Polyp; Uterine Bleeding; Endometrium; Senility

Outcome Measures

Primary Outcomes (2)

• Intensification of pain during and after the procedure

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

  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

  up to 6 months

Secondary Outcomes (3)

• Cervical passage time

  up to 6 months

• Occurrence of a vasovagal reaction

  up to 6 months

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

  up to 6 months

Study Arms (3)

1 (estradiol)

ACTIVE COMPARATOR

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

Drug: estradiol

2 (hyaluronic acid)

ACTIVE COMPARATOR

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

Drug: Hyaluronic acid

3 (control)

NO INTERVENTION

no preparation of the cervix - arm without medication

Interventions

estradiol DRUG

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

1 (estradiol)

Hyaluronic acid DRUG

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

2 (hyaluronic acid)

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 45-90 years
• uterine cavity focal lesion, abnormal uterine bleeding

You may not qualify if:

• drug allergy
• no consent to the procedure or participation in the study

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

Estradiol; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Robert Jach, Prof.

  Jagiellonian University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 24, 2023
• Study Start: June 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 31, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)