Ignite Creation Date:
2024-05-06 @ 7:12 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02497547
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2015-07-06
Brief Title:
An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy
Sponsor:
PepTonic Medical AB
Organization:
PepTonic Medical AB
Study Overview
Official Title:
A Phase 2b Double-blind Randomized Parallel Placebo-Controlled Multiple-Dose Study to Evaluate the 12-week Efficacy of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Up to 50 of postmenopausal women frequently suffer from atrophic vaginitis or vaginal atrophy with symptoms including vaginal dryness irritation burning itching or discomfort Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner drier and less elastic due to lack of estrogen In addition vaginal atrophy is associated with an increased pH which creates an environment more susceptible to infections
Menopausal hormone therapy is a common treatment for vaginal atrophy However menopausal hormone therapy has been shown to coincide with an increased incidence of breast cancer heart attack and stroke Some women experience adverse reactions such as uterine bleeding perineal pain and breast pain with menopausal hormone therapy Many women are also reluctant to initiate estrogen treatment due to a general negative view of menopausal hormone therapy in the society There are also many contraindicated conditions like undiagnosed vaginal bleeding thromboembolic disease breast cancer other estrogen-sensitive cancers or liver disease Women suffering from vaginal atrophy and presenting with these conditions have extremely limited options for effective therapy
Oxytocin is a peptide hormone normally released into the circulation via the pituitary Oxytocin has been shown in vitro to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women Local application of oxytocin in the form of a vaginal gel Vagitocin has been investigated in previous studies on postmenopausal women as a new effective and safe option for the treatment of vaginal atrophy Vagitocin appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal growth reducing symptoms of vaginal atrophy and increasing the patients wellbeing and quality of life Overall treatment with Vagitocin was safe and well tolerated by the subjects in the studies
In this study the clinical efficacy of Vagitocin as a potential treatment for postmenopausal women suffering from moderate to severe symptoms of vaginal atrophy vaginal irritationitching and vaginal discomfort andor pain associated with sexual activity will be explored In addition the dose relationship and lowest effective dose of Vagitocin will be investigated
Menopausal hormone therapy is a common treatment for vaginal atrophy However menopausal hormone therapy has been shown to coincide with an increased incidence of breast cancer heart attack and stroke Some women experience adverse reactions such as uterine bleeding perineal pain and breast pain with menopausal hormone therapy Many women are also reluctant to initiate estrogen treatment due to a general negative view of menopausal hormone therapy in the society There are also many contraindicated conditions like undiagnosed vaginal bleeding thromboembolic disease breast cancer other estrogen-sensitive cancers or liver disease Women suffering from vaginal atrophy and presenting with these conditions have extremely limited options for effective therapy
Oxytocin is a peptide hormone normally released into the circulation via the pituitary Oxytocin has been shown in vitro to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women Local application of oxytocin in the form of a vaginal gel Vagitocin has been investigated in previous studies on postmenopausal women as a new effective and safe option for the treatment of vaginal atrophy Vagitocin appeared to reverse the manifestation of vaginal atrophy by stimulating vaginal mucosal growth reducing symptoms of vaginal atrophy and increasing the patients wellbeing and quality of life Overall treatment with Vagitocin was safe and well tolerated by the subjects in the studies
In this study the clinical efficacy of Vagitocin as a potential treatment for postmenopausal women suffering from moderate to severe symptoms of vaginal atrophy vaginal irritationitching and vaginal discomfort andor pain associated with sexual activity will be explored In addition the dose relationship and lowest effective dose of Vagitocin will be investigated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None