E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaginal atrophy in postmenopausal women |
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E.1.1.1 | Medical condition in easily understood language |
The combination of vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful are known as vaginal atrophy |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047782 |
E.1.2 | Term | Vulvovaginal atrophy |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 primary objective is to investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane. |
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E.2.2 | Secondary objectives of the trial |
The safety objective is to investigate the safety and tolerability of topical Vagitocin treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to screening.
2. > 40 years of age.
3. Moderate to severe symptoms of at least one of the following criteria of vulvar and vaginal atrophy associated with the menopause, according to the patient’s self-assessement: vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, or presence of vaginal bleeding associated with sexual activity.
4. Atrophic mucosa according to the investigator’s assessment.
5. Signed Informed Consent. |
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E.4 | Principal exclusion criteria |
1. Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline.
2. Usage of any lubricant for intra-vaginal administration at baseline.
3. Vaginal bleeding of unknown origin.
4. Vaginal pH ≤ 5.0.
5. Any ongoing uro-genital infection within 7 days prior to baseline.
6. Body Mass Index (BMI) >30 kg/m2.
7. Systolic Blood Pressure > 150 mmHg and Diastolic Blood Pressure > 90 mmHg at baseline.
8. Any concurrent known or suspected tumor disease as judged by the investigator.
9. Clinically significant medical history (excluding medically well-controlled hypertension and hypercholesterolemia), abnormal findings from physical examinations, vital signs, cytology, histology, US examination of uterus and ovaries or laboratory analyses that may interfere with the trial objectives or compromise the safety of the patient as judged by the Investigator.
10. Concurrent and diagnosed nephrological or hepatic disorder
11. Diagnosed with HIV, Hepatitis B or C
12. Known or suspected drug or alcohol abuse, within 12 months prior to baseline.
13. Known or suspected allergy to any ingredient of the trial product.
14. Incapacity to perform trial procedures, as judged by the investigator.
15. Participation in any other interventional clinical trial within 3 months prior to baseline. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
7 weeks after first IMP administration |
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E.5.2 | Secondary end point(s) |
• Change in percentage points of superficial cells from baseline visit to 2 (Visit 2) weeks of treatment.
• Change in maturation value from baseline visit to 2 (Visit 2) and 7 (Visit 3) weeks of treatment.
• Change in vaginal pH from baseline visit to 2 (Visit 2) and 7 (Visit 3) weeks of treatment.
• Visual appearance of the vaginal mucosa after 2 (Visit 2) and 7 (Visit 3) weeks of treatment
• Patients´ self-assessment of the most bothersome symptom after 2 (Visit 2), 7 (Visit 3) weeks of treatment and at the telephone follow-up after 9 weeks.
• Histological assessment after 2 (Visit 2) and 7 weeks (Visit 3) of treatment.
• Change in score in selected items of WHQ/SSP from baseline visit to 7 (Visit 3) weeks of treatment and at the telephone follow-up after 9 weeks.
The safety endpoint is the incident and severity of reported AEs. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2, 7 and 9 weeks after first IMP administration. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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 | 3 |
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
|
The end of the trial is the last telephone follow-up for the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |