An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
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
irritation/itching and vaginal discomfort and/or pain associated with sexual activity will be
explored. In addition, the dose relationship and lowest effective dose of Vagitocin will be
investigated.