E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
Long-lasting pain around the vaginal opening causing severe pain during vaginal intercourse and tampon insertion. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The reduction of patient self-reported dyspareunia and/or pain at tampon insertion as measured by Visual Analogue Scale 0 (no pain) to 100 (worst pain imaginable) |
|
E.2.2 | Secondary objectives of the trial |
The reduction of pelvic floor hyperactivity/tonus, measured with a vaginal manometer, safety aspects and effect duration of BTA, influence on quality of life and psychosexual evaluation. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age 18-40 years
• PVD defined as significant pain at vestibular contact and vaginal entry (VAS ≥ 6 at the tampon test or severe pain, preventing intercourse)
• Duration of symptoms of ≥ 3 months
• Nullipara.
• Patients who are willing to participate in the study after it has been explained orally and in writing will be included.
|
|
E.4 | Principal exclusion criteria |
• Local infection, dermatological conditions or other causes to dyspareunia,
• Major psychiatric or medical disease (peripheral motor neurological disease such as myasthenia gravis, amyotrophic lateral sclerosis or Lambert-Eaton syndrome and diabetes)
• Pregnancy
• Pelvic floor deficiency with urine and or flatulence incontinence.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Pain score in millimetres from "no pain" will be analysed as a continuous variable and compared between groups. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
The patients will be asked to indicate with an X on a 100 mm long line marked with "no pain" to the left hand side and "worst imaginable pain" at the right hand side (Visual Analogue Scale- VAS) how much pain has during vaginal intercourse and/or tampon insertion. The first evaluation is before randomisation and treatment (baseline) and related to experienced pain the last month. The patients will then regularly report weekly in a diary the pain during vaginal intercourse and/or tampon insertion and also report at the follow ups, see below. |
|
E.5.2 | Secondary end point(s) |
Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups.
The hyperactivity of the pelvic floor muscles will be analysed by vaginal pressure measurements using a plastic catheter (4 mm) with a pressure transducer at the top. Resting tonus, maximum contraction strength and 10 s endurance of contraction will be measured in cm H2O.
Questionnaires on general health and reproductive health will be filled out at baseline. Questionnaires on sexual dysfunction and distress and quality of life will be filled out.
• Female Sexual Function Index (FSFI)
• Female Sexual Distress Scale (FSDS)
• Quality of life (WHOQOL-BRIEF, Swedish version and EQ-5D)
• PSS (perceived stress scale),
• Anxiety questionnaire (Spence, Swedish version). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Serious adverse events will immediately be reported to the research nurse and responsible gynaecologists (investigators). Any minor adverse events will be reported in the weekly diary and checked for at all follow ups.
The vaginal pressure will be measured before treatment and at all follow-ups;
Visit 2, 4-6 weeks after baseline
Visit 3, 12 weeks after baseline
Visit 4, 16-18 weeks after baseline
Visit 5, 6 months after baseline
Visit 6, final study visit, 12 months from baseline.
The questionnaires will be filled out at baseline. visit 3 , 5 and 6.
• |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |