Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women
Nyckelord
Abstrakt
Datum
| Senast verifierad: | 08/31/2011 |
| Först skickat: | 08/15/2010 |
| Beräknad anmälan inlämnad: | 09/11/2011 |
| Först publicerad: | 09/12/2011 |
| Senaste uppdatering skickad: | 09/11/2011 |
| Senaste uppdatering publicerad: | 09/12/2011 |
| Faktiskt startdatum för studien: | 07/31/2010 |
| Uppskattat primärt slutdatum: | 05/31/2011 |
| Beräknat slutfört datum: | 05/31/2011 |
Tillstånd eller sjukdom
Intervention / behandling
Drug: Oxytocin, Intravaginal administration
Drug: Placebo, Intravaginal administration
Fas
Armgrupper
| Ärm | Intervention / behandling |
|---|---|
| Experimental: Oxytocin, Intravaginal administration | Drug: Oxytocin, Intravaginal administration Gel for intravaginal use, 600 IU once per day for 2 weeks followed by 600 IU twice a week for ten weeks |
| Placebo Comparator: Placebo, Intravaginal administration | Drug: Placebo, Intravaginal administration Gel for intravaginal use of identical appearance as active substance, once per day for two weeks followed by twice a week for ten weeks |
Urvalskriterier
| Åldrar berättigade till studier | 40 Years Till 40 Years |
| Kön som är berättigade till studier | Female |
| Accepterar friska volontärer | Ja |
| Kriterier | Inclusion Criteria: - 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 Criteria: - 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 |
Resultat
Primära resultatåtgärder
1. The Maturation Value (MV) [12 weeks of oxytocin treatment as compared to placebo]
Sekundära resultatåtgärder
1. Vaginal Atrophy [12 weeks]
2. Quality of Life [2 and 12 weeks]
3. The Maturation Value [2 weeks]
4. Vaginal pH [2 and 12 weeks]
5. Concentration of Oxytocin in serum [0-60 min after drug admin.]
6. Clinician evaluation of vaginal mucosal appearance [2 and 12 weeks]
7. Laboratory assessments [2 and 12 weeks]
8. Concentration of 17 beta-estradiol in serum [12 weeks]
9. Vital signs [2 and 12 weeks]
