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Clinical trial

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

ID
Name
1072.6120.128.2021
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2022-12-30
Trial end
2023-01-31
Status
Completed
Treatment
estradiol
estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure
Arms:
1 (estradiol)
Hyaluronic acid
hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure
Arms:
2 (hyaluronic acid)
Size
96
Primary endpoint
Intensification of pain during and after the procedure
up to 6 months
The need of cervical dilation
up to 6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 96, 'type': 'ACTUAL'}}
Updated at
2023-03-24

1 organization

2 products

3 indications

Organization
Jagiellonian University
Product
estradiol
Indication
Uterine Polyp
Indication
Abnormal Uterine Bleeding
Indication
Endometrium
Product
Hyaluronic acid