Study of Oxytocin to Treat Vaginal Atrophy in Postmenopausal Women
Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
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.