E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaginal atrophy in postmenopausal women |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047782 |
E.1.2 | Term | Vulvovaginal atrophy |
|
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 |
To investigate if topical oxytocin can reverse vaginal atrophy, assessed by cytological examination of the vaginal mucosal epithelium, in postmenopausal women after 12 weeks of treatment as compared to placebo. |
|
E.2.2 | Secondary objectives of the trial |
If topical oxytocin reverses vaginal atrophy, by cytological examination after 2 weeks of treatment as compared to placebo Effects of topical oxytocin on vaginal atrophy, by histological examination Effects of topical oxytocin on vaginal pH Effects of topical oxytocin on visual appearance of the vaginal mucosa Effects of topical oxytocin on subject quality of life Investigate systemic exposure of oxytocin after topical administration Effects of topical oxytocin on 17β-estradiol plasma concentrations Investigate safety and tolerability of topical oxytocin treatment Investigate subject treatment compliance with topical oxytocin |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Signed informed consent -≥ 40 years of age -Naturally postmenopausal women, completely without menstrual bleedings for at least 4 years prior to screening. -FSH plasma levels ≥ 40IU/L and 17-beta-estradiol levels < 70 pmol/L -Vaginal pH > 5.0 -BMI ≤ 29 kg/m2 -Vaginal atrophy verified by cytological assessment of the vaginal mucosal epithelium. Vaginal atrophy is defined as ≤ 5% superficial cells. |
|
E.4 | Principal exclusion criteria |
-Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effect within 3 months prior to screening -Any condition that is a contraindication to treatment with sex steroids -Vaginal bleeding of unknown origin -Any untreated urogenital infection within 7 days prior to inclusion -Any prior or concurrent malignant disease or endometrial hyperplasia -Cervical cytology ≥ CIN 1 assessed during screening -Systolic Blood Pressure ≥ 140 mmHg or diastolic Blood Pressure ≥ 90 mmHg at screening -Concurrent and diagnosed nephrologic or hepatic disorder |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-Cytological assessment (pap smear) of vaginal atrophy assessed as percentage of superficial, parabasal and intermediary cells and measured after 12 weeks of treatment with oxytocin/placebo. |
|
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 | 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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetic part of study |
|
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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 | Information not present in EudraCT |
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
|
End of trial is defined as last patient last visit. |
|
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 | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |