Discomfort or pain during hysteroscopy Signs and Symptoms Discomfort or pain during hysteroscopy
Conditions
Interventions
Study medication (active or placebo) will be sprayed onto the cervix in 10 metered dose sprays (to give a total of 75 mg lidocaine and 25 mg prilocaine, or placebo). The first spray will be to the cer
the spraying pattern will be repeated immediately to complete 10 sprays in total. The time of final spray application will be recorded. After a minimum of 5 minutes and no more than 10 minutes, the ex
Sponsors
Plethora Solutions Limited (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: A subject will be invited to participate if she meets the following inclusion criteria: 1. Healthy, pre-menopausal female who requires hysteroscopy 2. Aged 18 - 50 years inclusive 3. Clinically insignificant medical history and clinical examination other than the underlying condition requiring treatment, in the opinion of the Investigator 4. Post menstruation, but prior to ovulation at the time of the procedure and has a negative pregnancy test 5. Able to understand and complete the visual analogue pain scale (VAPS) and 4-point discomfort/pain scale, in the opinion of the Investigator 6. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: A subject will be excluded from study participation if she meets any of the following criteria: 1. Contraindication to hysteroscopy 2. Known hypersensitivity to amide-type local anaesthetics 3. Received another investigational product within the previous 3 months 4. Current history of alcohol or drug abuse such that the subject is unable to comply with the study procedures or has resulting clinically significant organ damage, in the opinion of the Investigator 5. Clinically-significant medical history or clinical finding (e.g. bleeding diathesis or coagulopathy) that would affect the subject's ability to take part in the study, in the opinion of the Investigator 6. Previous hysteroscopy with technical difficulties or side effects 7. Used lidocaine or prilocaine preparation within 6 hours before the hysteroscopy procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of PSD502 in relieving discomfort/pain at placement of the tenaculum on the anterior lip of the cervix assessed using a 100 mm VAPS in subjects undergoing hysteroscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of PSD502 in relieving discomfort/pain during insertion of the hysteroscope as assessed using a VAPS in subjects undergoing hysteroscopy 2. To evaluate the efficacy of PSD502 in relieving discomfort/pain during examination of the uterine cavity as assessed using a VAPS in subjects undergoing hysteroscopy 3. To evaluate the efficacy of PSD502 in relieving the worst discomfort/pain experienced during the entire hysteroscopy procedure using a 4-point discomfort/pain scale 4. To evaluate the need for additional analgesia in the 24 hours after the procedure 5. To evaluate the safety and tolerability of PSD502 administered to the cervix and vagina | — |
Countries
Poland
Outcome results
None listed