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Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women (OXYPEP002)

Primary Purpose

Vaginal Atrophy

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Oxytocin 100 i.u.

Oxytocin 400 i.u.

Placebo

About this trial

This is an interventional treatment trial for Vaginal Atrophy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline.
> 40 years of age.
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.
Atrophic mucosa according to the investigator's assessment.
Signed Informed Consent.

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.

Sites / Locations

Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin 100 i.u.

Oxytocin 400 i.u.

Placebo

Arm Description

N=24 patients are administrated Oxytocin 100 i.u. vaginally

N=24 patients are administrated Oxytocin 400 i.u. vaginally

N=16 patients are administrated placebo vaginally

Outcomes

Primary Outcome Measures

To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.

Change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3).

Secondary Outcome Measures

To investigate the safety and tolerability of topical Vagitocin treatment.

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 symptomafter 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.

Full Information

NCT ID

NCT01987804

First Posted

November 13, 2013

Last Updated

November 10, 2020

Sponsor

PepTonic Medical AB

Collaborators

Pharma Consulting Group AB

1. Study Identification

Unique Protocol Identification Number

NCT01987804

Brief Title

Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women

Acronym

OXYPEP002

Official Title

A Double-blind, Placebo Controlled Single Centre Trial to Evaluate the Dose-relationship of the Effects of Vaginally Administered Oxytocin on the Vaginal Mucosal Membrane in Postmenopausal Women With Vaginal Atrophy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PepTonic Medical AB

Collaborators

Pharma Consulting Group AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Up to 50% of all postmenopausal women, experience vaginal drynes, i.e. vaginal atrophy is a consequence due to the lack of estrogen. In addition, vaginal atrophy is associated with an increased pH, which creates an environment more susceptible to infections . The mucosal epithelium shows signs of severe senile atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells . Unlike some other menopausal symptoms (for instance hot flushes), vaginal symptoms generally persist or worsen with aging.Oxytocin is a peptide hormone and it is released systemically via the posterior pituitary. The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding. Oxytocin has also shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women, an effect which could be attributed either to the direct stimulation of new cell formation or to an increased production of other growth factors. The primary objective is to investigate the dose relationsship of topical administrated Vagitocin on the vaginal mucosal membrane, measured in the change (%)of superficial cells up to 7 weeks after baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vaginal Atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin 100 i.u.

Arm Type

Experimental

Arm Description

N=24 patients are administrated Oxytocin 100 i.u. vaginally

Arm Title

Oxytocin 400 i.u.

Arm Type

Experimental

Arm Description

N=24 patients are administrated Oxytocin 400 i.u. vaginally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

N=16 patients are administrated placebo vaginally

Intervention Type

Drug

Intervention Name(s)

Oxytocin 100 i.u.

Other Intervention Name(s)

Vagoticin

Intervention Type

Drug

Intervention Name(s)

Oxytocin 400 i.u.

Other Intervention Name(s)

Vagoticin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane.

Description

Change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3).

Time Frame

from baseline visit to 7 weeks of treatment

Secondary Outcome Measure Information:

Title

To investigate the safety and tolerability of topical Vagitocin treatment.

Description

Time Frame

From visit 2 to visit 7

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline. > 40 years of age. 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. Atrophic mucosa according to the investigator's assessment. Signed Informed Consent. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aino F Jonasson, M.D, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska University Hospital

City

Stockholm

State/Province

Huddinge

ZIP/Postal Code

14186

Country

Sweden

12. IPD Sharing Statement

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Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women

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