NCT02497547

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

Completed Phase 2 Last updated 20 October 2015

What this trial tests

Phase 2 trial testing Oxytocin in Atrophy in 227 participants. Completed in 1 July 2015.

Timeline

1 October 2014

Primary endpoint
1 July 2015

1 July 2015

Quick facts

Lead sponsor	PepTonic Medical AB
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	227
Start date	1 October 2014
Primary completion	1 July 2015
Estimated completion	1 July 2015
Sites	5 locations across Sweden

Drugs / interventions tested

• Oxytocin (OXYTOCIN) — full drug profile →
• Placebo

Conditions studied

• Atrophy — all drugs for Atrophy →

Sponsor

PepTonic Medical AB — full company profile →

Who can join

Adults 40 to 65, female only, with Atrophy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change from baseline to Week 12 in severity of vaginal atrophy symptom that has been self-identified by the subject as being the most bothersome to her in the vaginal atrophy questionnaire
  Time frame: After 12 weeks of treatment
  Vaginal atrophy symptoms: vaginal irritation and itching, dyspareunia, vaginal dryness, dysuria or presence of vaginal bleeding associated with sexual activity
• Change from baseline to Week 12 in % superficial cells (increase is positive)
  Time frame: After 12 weeks of treatment
• Change from baseline to Week 12 in Vaginal pH (decrease is positive)
  Time frame: After 12 weeks of treatment

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.