Vaginal atrophy in postmenopausal women MedDRA version: 14.1 Level: LLT Classification code 10047782 Term: Vulvovaginal atrophy System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Product Name: Vagitocin (oxytocin gel)
Product Code: Not applicable
Pharmaceutical Form: Vaginal gel
CAS Number: 50-56-6
Other descriptive name: OXYTOCIN
Concentration unit: IU international unit(s)
C
Sponsors
PeP-Tronic Medical AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.;Secondary Objective: The safety objective is to investigate the safety and tolerability of topical Vagitocin treatment.;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).;Timepoint(s) of evaluation of this end point: 7 weeks after first IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 2, 7 and 9 weeks after first IMP administration. | — |
Countries
Sweden
Contacts
Public ContactDan Markusson
PeP-Tonic Medical AB
Outcome results
None listed