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

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ClinicalTrials.gov Identifier: NCT01987804
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : November 21, 2013
Sponsor:
Collaborator:
Pharma Consulting Group AB
Information provided by (Responsible Party):
PepTonic Medical AB

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.

Condition or disease Intervention/treatment Phase
Vaginal Atrophy. Drug: Oxytocin 100 i.u. Drug: Oxytocin 400 i.u. Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin 100 i.u.
N=24 patients are administrated Oxytocin 100 i.u. vaginally
Drug: Oxytocin 100 i.u.
Other Name: Vagoticin

Experimental: Oxytocin 400 i.u.
N=24 patients are administrated Oxytocin 400 i.u. vaginally
Drug: Oxytocin 400 i.u.
Other Name: Vagoticin

Placebo Comparator: Placebo
N=16 patients are administrated placebo vaginally
Drug: Placebo



Primary Outcome Measures :
  1. To investigate the dose-relationship of topical Vagitocin on the vaginal mucosal membrane. [ Time Frame: from baseline visit to 7 weeks of treatment ]
    Change in percentage points of superficial cells from baseline visit (visit 1) to 7 weeks of treatment (Visit 3).


Secondary Outcome Measures :
  1. To investigate the safety and tolerability of topical Vagitocin treatment. [ Time Frame: From visit 2 to visit 7 ]

    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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Naturally postmenopausal or ooforectomized women, completely without menstrual bleedings for at least four years prior to baseline.
  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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987804


Locations
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Sweden
Karolinska University Hospital
Stockholm, Huddinge, Sweden, 14186
Sponsors and Collaborators
PepTonic Medical AB
Pharma Consulting Group AB
Investigators
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Principal Investigator: Aino F Jonasson, M.D, PhD Karolinska Institutet
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Responsible Party: PepTonic Medical AB
ClinicalTrials.gov Identifier: NCT01987804    
Other Study ID Numbers: OXYPEP002
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs