NCT05783479

Pharmacological Preparation of the Cervix for Hysteroscopy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 45 Years – 90 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Uterine Polyp
• Uterine Bleeding
• Endometrium; Senility

Interventions

Type	Name	Description
DRUG	estradiol	estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
DRUG	Hyaluronic acid	hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-30
• Completion: 2023-01-31
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

1 site across 1 country: Poland