Endometrial BiopsyNCT07046572
Methoxyflurane for IUD Insertion and Endometrial Biopsy
A study testing Methoxyflurane - Penthrox in people with Endometrial Biopsy and Intrauterine Devices, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT. Each participant will be randomly assigned to one of two arms: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Biopsy, Intrauterine Devices
- What is being tested?
- Methoxyflurane - Penthrox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jul 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any participant ≥18 years and ≤ 65 years presenting for an IUD insertion or endometrial biopsy
- For IUD insertion, only nulliparous patients
- English speaking participants only
- Availability of a ride home from the appointment
Who cannot join
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Misoprostol administration within 24 hours
- Breastfeeding
- Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
- Allergy to methoxyflurane
- Renal or liver disease
Show all 10Show fewer
- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
- Baseline vital signs of systolic blood pressure <100, diastolic blood pressure <60 and/or pulse <60.
- Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)
- Clinically evident respiratory impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
OPG
Toronto, Ontario, M5G 1Z5
Dr. Mara Sobel, MD, 416-586-8273, Mara.Sobel@sinaihealth.ca
Dr. Mara Sobel, MD
About this study
Official title: A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT.
Each participant will be randomly assigned to one of two arms:
- Intervention (3ml of Methoxyflurane via a Penthrox inhaler)
- Placebo (3ml of normal saline via an identical placebo Penthrox inhaler)
The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).
- Conditions
- Endometrial Biopsy, Intrauterine Devices
- Being tested
- Methoxyflurane - Penthrox, Placebo Penthrox inhaler
- Keywords
- methoxyflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxyflurane - PenthroxDrug
3ml of Methoxyflurane via a Penthrox inhaler
Placebo Penthrox inhalerOther
3ml of normal saline via an identical placebo Penthrox inhaler
| Study group | Role | What they receive |
|---|---|---|
| 3ml of Methoxyflurane | Experimental | 3ml of Methoxyflurane via a Penthrox inhaler Receives: Drug: Methoxyflurane - Penthrox |
| 3ml of normal saline | Placebo comparator | 3ml of normal saline via an identical placebo Penthrox inhaler Receives: Other: Placebo Penthrox inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global pain score
Patient reported pain by the 100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable), higher scores indicate greater pain intensity.
Measured: 5-minutes following the completion of the procedure
Secondary outcomes (6)
Pain scores during procedure
Patient-reported verbal pain scores on a scale from 0 (no pain) to 10 (worst pain imaginable) at the following timepoints: baseline before inhaler, baseline after inhaler, insertion of speculum, tap cervix with sound, placement of tenaculum, sounding (IUD only), IUD insertion/endometrial biopsy, and 1-minute post-procedure. Higher scores indicate greater pain intensity.
Measured: During the procedure
Immediate complications and side effects
Provider-reported via written survey
Measured: Immediately after the completion of the procedure
Difficulty for provider to complete the procedure
Provider-reported on Likert scale, minimum 1 (least difficult) and maximum 5 (most difficult). Higher score indicates greater difficulty.
Measured: Immediately after the completion of the procedure
Length of time for procedure completion
Recorded via stopwatch
Measured: During the procedure
Patient satisfaction
Patient-reported via a written survey
Measured: Immediately after the completion of the procedure
Patient Satisfaction
Patient-reported via a 5-point Likert scale: very unsatisfied (1) to very satisfied (5). Higher score indicates greater dissatisfaction.
Measured: Immediately after the completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start24 Jul 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial BiopsyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a double-blind randomized controlled trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of two arms: 1) intervention (3ml of Methoxyflurane via a Penthrox inhaler) or 2) placebo (3ml of normal saline via an identical placebo Penthrox inhaler). The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Matthew Morton Research Award
- Responsible party
- Principal investigator, Mara Sobel, Mount Sinai Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046572
- Sponsor's protocol ID
- REB 25-0041-A
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy
- ClinicalTrials.gov ID
- NCT07046572
- Acronym / sponsor ID
- REB 25-0041-A
- Conditions
- Endometrial Biopsy, Intrauterine Devices
- Keywords
- methoxyflurane
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Matthew Morton Research Award
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Jul 2025 (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.
The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and/or endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT.
Each participant will be randomly assigned to one of two arms:
- Intervention (3ml of Methoxyflurane via a Penthrox inhaler)
- Placebo (3ml of normal saline via an identical placebo Penthrox inhaler)
The primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The proposed study is a double-blind randomized controlled trial. Participants will be recruited from Mount Sinai Hospital outpatient gynecology clinics. Recruitment, consent, randomization, procedure, and post-procedure survey will occur during the same visit. Each participant will be randomly assigned to one of two arms: 1) intervention (3ml of Methoxyflurane via a Penthrox inhaler) or 2) placebo (3ml of normal saline via an identical placebo Penthrox inhaler). The primary outcome will be a global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) following the procedure.
| Arm | Type | Receives |
|---|---|---|
| 3ml of Methoxyflurane | Experimental | Drug: Methoxyflurane - Penthrox3ml of Methoxyflurane via a Penthrox inhaler |
| 3ml of normal saline | Placebo comparator | Other: Placebo Penthrox inhaler3ml of normal saline via an identical placebo Penthrox inhaler |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any participant ≥18 years and ≤ 65 years presenting for an IUD insertion or endometrial biopsy
- For IUD insertion, only nulliparous patients
- English speaking participants only
- Availability of a ride home from the appointment
Key exclusion criteria (10 listed)
- Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours
- Misoprostol administration within 24 hours
- Breastfeeding
- Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)
- Allergy to methoxyflurane
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 |
|---|---|---|
| Methoxyflurane - Penthrox3ml of Methoxyflurane via a Penthrox inhaler | Drug | 3ml of Methoxyflurane |
| Placebo Penthrox inhaler3ml of normal saline via an identical placebo Penthrox inhaler | Other | 3ml of normal saline |
Primary outcome
Global pain score
Time frame: 5-minutes following the completion of the procedure
Patient reported pain by the 100 mm Visual Analogue Scale (VAS), minimum value 0 (no pain at all) and maximum value 100 (worst pain imaginable), higher scores indicate greater pain intensity.
6 secondary outcomes
Pain scores during procedure
Time frame: During the procedure
Immediate complications and side effects
Time frame: Immediately after the completion of the procedure
Difficulty for provider to complete the procedure
Time frame: Immediately after the completion of the procedure
Length of time for procedure completion
Time frame: During the procedure
Patient satisfaction
Time frame: Immediately after the completion of the procedure
Patient Satisfaction
Time frame: Immediately after the completion of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methoxyflurane - Penthrox in people with Endometrial Biopsy and Intrauterine Devices, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global pain score (time frame: 5-minutes following the completion of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2025.