Status:
COMPLETED
Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women
Lead Sponsor:
PepTonic Medical AB
Conditions:
Postmenopause
Vaginal Atrophy
Eligibility:
FEMALE
40+ years
Phase:
PHASE2
Brief Summary
Up to 50% of all postmenopausal women, experience vaginal dryness, irritation, burning, itching or discomfort, which often make sex to become difficult or painful. These symptoms combined are known as...
Eligibility Criteria
Inclusion
- Signed Informed Consent
- at least 40 years of age
- naturally postmenopausal women, completely without menstrual bleedings for at least four years prior to screening.
- FSH plasma levels at least 40 IU/L and 17β-estradiol levels less than 70pmol/L
- Vaginal pH more than 5.0
- BMI at most 29 kg/m2
- Vaginal atrophy verified by cytological assessment of the vaginal mucosal epithelium. Vaginal atrophy is defined as at most 5% of superficial cells.
Exclusion
- Usage of any sex steroids including phytoestrogens, hormonal intra-uterine device or herbal medicinal products with known estrogenic effects within 3 months prior to screening.
- Usage of any lubricant for intra-vaginal administration at inclusion
- 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 at least CIN 1 assessed during screening
- Clinically significant medical history (excluding medically well-controlled hypertension and hypercholesterolemia), findings from physical examinations, vital signs, cytology, histology or laboratory analyses that may interfere with the study objectives or compromise the safety of the subject as judged by the Investigator.
- Systolic Blood Pressure at least 140 mmHg or Diastolic Blood Pressure at least 90 mmHg at screening
- Participation in any other interventional clinical trial within 3 months prior to screening
- Known or suspected drug or alcohol abuse, within 12 months prior to screening
- Concurrent and diagnosed nephrologic or hepatic disorder
- Diagnosed with HIV, Hepatitis B or C
- Known or suspected allergy to any ingredient of the study product
- Incapacity to perform study procedures, as judged by the Investigator
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01432470
Start Date
August 1 2010
End Date
June 1 2011
Last Update
September 13 2011
Active Locations (3)
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1
Karolinska University Hospital-Huddinge
Huddinge, Sweden, SE-141 86
2
Uppsala University Hospital
Uppsala, Sweden, SE-751 85
3
Northwick Park & St Marks Hospital NHS Trust
Harrow Middlesex, United Kingdom, HA1 3UJ