Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01432470
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2010-08-16
Brief Title:
Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women
Sponsor:
PepTonic Medical AB
Organization:
PepTonic Medical AB
Study Overview
Official Title:
A Double-blind Placebo Controlled Multi-centre Study to Evaluate the Effects of Topical Oxytocin on Vaginal Atrophy in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2011-09
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 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 vaginal atrophy Vaginal atrophy is a consequence of the lining tissue of the vagina becoming thinner drier and less elastic 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 atrophy and cytological examination demonstrate increased number of the basal and parabasal cells and reduced number of superficial cells
Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy However some women experience adverse reactions such as uterine bleeding perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society
Oxytocin is a peptide hormone which is normally released into the circulation via the pituitary The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding In addition oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women
Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment A similar effect was not seen in the placebo group which indicated a difference between placebo and active treatment However the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy
Due to the limitations of estrogens in the treatment of vaginal atrophy many postmenopausal women are left without an effective remedy Hence there is a need for alternative non-estrogenic treatments of this indication The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy
The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy as assessed by cytological examination of the vaginal mucosal epithelium in postmenopausal women after 12 weeks of treatment as compared to placebo
Estrogen treatment either as hormone replacement therapy or topical application is a common treatment for vaginal atrophy However some women experience adverse reactions such as uterine bleeding perineal pain and breast pain and many women are also reluctant to use estrogens due to a general negative view to this topic in the society
Oxytocin is a peptide hormone which is normally released into the circulation via the pituitary The most well known effects of oxytocin are its roles in female reproduction such as facilitation of birth and breast feeding In addition oxytocin has in vitro been shown to exert positive effects on the proliferation of human vaginal mucosal cells from postmenopausal women
Considering the stimulatory effects of oxytocin on vaginal mucosal cell proliferation topical application of oxytocin to the vaginal mucosa may be an approach to treat vaginal atrophy In one previous placebo-controlled study on 20 postmenopausal women suffering from vaginal atrophy a gel containing oxytocin for topical intra-vaginal administration was applied daily for seven days The results indicated that for subjects receiving topical oxytocin the vaginal atrophy assessed by histological examination was reversed after treatment A similar effect was not seen in the placebo group which indicated a difference between placebo and active treatment However the limited number of exposed subjects in this pilot study necessitates a larger study in order to generate conclusive proof of concept data for the effects of oxytocin on vaginal atrophy
Due to the limitations of estrogens in the treatment of vaginal atrophy many postmenopausal women are left without an effective remedy Hence there is a need for alternative non-estrogenic treatments of this indication The present study is aiming to investigate the efficacy of topical oxytocin in the treatment of vaginal atrophy
The main objective of this study is to investigate if topical oxytocin can reverse vaginal atrophy as assessed by cytological examination of the vaginal mucosal epithelium in postmenopausal women after 12 weeks of treatment as compared to placebo
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