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
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Atrophy.||Drug: Oxytocin 100 i.u. Drug: Oxytocin 400 i.u. Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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).
- 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.
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
|Karolinska University Hospital|
|Stockholm, Huddinge, Sweden, 14186|
|Principal Investigator:||Aino F Jonasson, M.D, PhD||Karolinska Institutet|