Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03683914

Enrollment

102

Registered

2018-09-25

Start date

2018-09-30

Completion date

2019-02-28

Last updated

2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Office Hysteroscopy

Brief summary

To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

Detailed description

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body.Cervical ripening is made possible by the use of medication through different routes.The most commonly used agent is misoprostol,a synthetic prostaglandin E1 (PGE1) analogue that is frequently administered in off-label use in obstetrics and gynaecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening.In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Interventions

DRUGDinoprostone 3Mg Vaginal Tablet

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.

DRUGplacebo vaginal tablet

1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Menopausal patients with an indication for ofﬁce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ﬁndings)

Exclusion criteria

* • Nulliparous patients * patients with cervical pathology * retroverted uterus (detected by transvaginal ultrasound) * previous cervical surgery * patients with severe vaginal bleeding * allergy or contraindications to dinoprostone therapy (asthma, liver, kidney, or heart disease).

Design outcomes

Primary

Measure	Time frame	Description
Intensity of pain	an expected average of 10 minutes	Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10

Secondary

Measure	Time frame	Description
Intensity of pain	30 minutes after the procedure	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10
Operative time	an expected average 10 minutes	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026