Dinoprostone TimingPhase 3NCT04085757

Optimal Timing of Dinoprostone Administration Prior to Office Hysteroscopy

A Phase 3 study testing long interval dinoprostone and short interval dinoprostone in people with Dinoprostone Timing, run by Cairo University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to determine whether dinoprostone administered 10 hours before office hysteroscopy can relieve pain more effectively compared with dinoprostone administered 3 hours before office hysteroscopy. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Dinoprostone Timing
What is being tested?: long interval dinoprostone and short interval dinoprostone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 2 sitesEgypt
Study dates: 15 Sep 2019to 1 Jan 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Nulliparous patients who have an indication for office hysteroscopy

Who cannot join

Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, allergy to dinoprostone

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

faculty of medicine Cairo university
Giza, 11231
Tertiary referral hospital
Giza

Other trials in Egypt

About this study

Official title: Determining the Optimal Time Interval Between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized Double-Blind Trial

Conditions: Dinoprostone Timing
Being tested: long interval dinoprostone, short interval dinoprostone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

long interval dinoprostoneDrug
A small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
short interval dinoprostoneDrug
A small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablet(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

Study groups in NCT04085757
Study group	Role	What they receive
long interval dinoprostone	Experimental	A small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy. Receives: Drug: long interval dinoprostone
short interval dinoprostone	Active comparator	A small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablets(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy. Receives: Drug: short interval dinoprostone

What is being measured

The primary outcome is the main question the study is designed to answer.

Intensity of pain
Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable)
Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 20191 Jan 2020

First posted11 Sep 2019
Study start15 Sep 2019
Primary completion15 Dec 2019
Study completion1 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dinoprostone TimingStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04085757
Sponsor's protocol ID: dinoprostone timing
Status last verified: May 2021
First submitted: 7 Sep 2019
Last updated: 7 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Rund NMA, El Shenoufy H, Islam BA, El Husseiny T, Nassar SA, Mohsen RA, Alaa D, Gad Allah SH, Bakry A, Refaat R, Gehad MA, Kotb MMM, Osman OM, Ashour ASA, Ali AS, Taher A, Kholaif K, Hashem AT, Elsallamy AAH, Nour DA, Dahab S, Talaat B, Almohammady M. Determining the Optimal Time Interval between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized, Double-blind Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):85-93. doi: 10.1016/j.jmig.2021.06.021. Epub 2021 Jul 1.
PubMed 34217851

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determining the Optimal Time Interval Between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized Double-Blind Trial
ClinicalTrials.gov ID: NCT04085757
Acronym / sponsor ID: dinoprostone timing
Conditions: Dinoprostone Timing
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 15 Sep 2019 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 1 Jan 2020 (actual)
First posted: 11 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
long interval dinoprostone	Experimental	Drug: long interval dinoprostoneA small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
short interval dinoprostone	Active comparator	Drug: short interval dinoprostoneA small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablets(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Nulliparous patients who have an indication for office hysteroscopy

Key exclusion criteria (1 listed)

Parous patients, menopausal patients and patients with cervical pathology, and previous cervical surgery will be excluded from the study. Moreover, patients with severe vaginal bleeding, allergy to dinoprostone

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
long interval dinoprostoneA small envelope including two labeled plastic bags (A \& B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.	Drug	long interval dinoprostone
short interval dinoprostoneA small envelope including two labeled plastic bags (A\& B) (each bag containing either 1 dinoprostone tablet(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.	Drug	short interval dinoprostone

Primary outcome

Intensity of pain
Time frame: intraoperative
Intensity of pain by visual analog scale from 0(no pain) to 100 mm(worst pain imaginable)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Derived from this study: PubMed 34217851Rund NMA, El Shenoufy H, Islam BA, El Husseiny T, Nassar SA, Mohsen RA, Alaa D, Gad Allah SH, Bakry A, Refaat R, Gehad MA, Kotb MMM, Osman OM, Ashour ASA, Ali AS, Taher A, Kholaif K, Hashem AT, Elsallamy AAH, Nour DA, Dahab S, Talaat B, Almohammady M. Determining the Optimal Time Interval between Vaginal Dinoprostone Administration and Diagnostic Office Hysteroscopy in Nulliparous Women: A Randomized, Double-blind Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):85-93. doi: 10.1016/j.jmig.2021.06.021. Epub 2021 Jul 1.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AHMED SAMY principal investigator

Cairo University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing long interval dinoprostone and short interval dinoprostone in people with Dinoprostone Timing, run by Cairo University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of pain (time frame: intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04085757, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.